[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-ovarian-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-ovarian-cancer-ajcc-v8":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,70,96,154,193,229,261,284,336,361,400,440],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100404756","phase-2-measuring-the-effects-of-talazoparib-in-patients-with-advanced-cancer-and-dna-repair-variations-100404756",false,"NCT04550494","Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations","A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response","Inclusion Criteria:\n\n* Adult patients with solid tumors and documented germline or somatic aberrations in genes involved in DNA damage response (DDR) and whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options. Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable for determination of eligibility\n* Patients with the following germline or somatic genetic aberrations will be eligible based on compelling preclinical and\u002For clinical data suggesting that these deleterious mutations confer sensitivity to PARP inhibitors; no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene will be enrolled\n\n  * Deleterious BRCA1 or BRCA2 mutations\n  * Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN\n  * A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L\n* Age \\>= 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Life expectancy of greater than 3 months\n* Leukocytes \\>= 3,000\u002FmcL\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 10 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (=\\\u003C 3 x upper limit of normal in the presence of documented Gilbert's syndrome or liver metastases at baseline)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal\n* Creatinine =\\\u003C 1.5 x institutional upper limit of normal OR Creatinine clearance (CrCl) \\>= 60 mL\u002Fmin\u002F1.73m\\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73m\\^2\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 20 mm (\\>= 2 cm) by chest x-ray or as \\>= 10 mm (\\>= 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Patients must have a tumor site amenable to biopsy. If avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST measurements\n* The effects of talazoparib on the developing human fetus are unknown. For this reason and because PARP inhibitors are known to be teratogenic, women of child-bearing potential must agree to use a highly effective method of contraception for the duration of study participation and for at least 7 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male patients with female partners of reproductive potential and pregnant partners who are treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for at least 4 months after completion of talazoparib administration\n* Patients must be able to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube) administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients must have recurrent, locally advanced or metastatic disease\n* Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention, except for those patients without SOC or for whom talazoparib is SOC\n* PATIENTS WITH OVARIAN CANCER:\n* All patients with ovarian cancer should have one prior platinum-based therapy\n* Patients with ovarian cancer with platinum-sensitive disease are eligible. Patients with platinum-refractory disease are not eligible\n* Patients with gBRCAm ovarian cancer must also have progressed on a PARP inhibitor. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH PANCREATIC CANCER:\n* All patients with pancreatic cancer should have received prior platinum-containing therapy in the metastatic setting\n* PATIENTS WITH BREAST CANCER:\n* Patients with HER2+ breast cancer should have had 2 prior systemic lines of therapy in the metastatic setting, including anti-HER2 therapy\n* Patients with breast cancer who are eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals must have had prior PARP inhibitor as per FDA indication. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH GASTRIC CANCER:\n* Patients with HER2+ gastric cancer should have had received anti-HER2 therapy in the metastatic setting\n* PATIENTS WITH PROSTATE CANCER:\n* Patients with prostate cancer who are eligible for a PARP inhibitor by FDA approvals must have had prior PARP inhibitor for eligibility. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* All patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on prior therapy\n* Patients with castration resistant prostate cancer must have castrate levels of testosterone (\\\u003C 50 ng\u002FdL \\[1.74 nmol\u002FL\\])\n* Patients with metastatic hormone receptor (HR) prostate cancer and mutations in either BRCA1, BRCA2, or ATM should continue to receive anti-androgen receptor (anti-AR) therapy\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter (6 weeks for nitrosoureas or mitomycin C). Patients must be \\>= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be \\>= 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events\n* Patients who have had prior treatment with talazoparib are ineligible\n* Patients who have had prior monoclonal antibody therapy must have completed that therapy \\>= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment) except for monoclonal antibody therapies that have been proven to be safe when combined with PARP inhibitor (PARPi) treatment (such as anti-PD-1\u002FPD-L1 and anti-HER2), which must be completed \\>= 4 weeks prior to enrollment\n* Patients who are receiving any other investigational agents\n* Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for \\>= 1 month without requiring steroid and anti-seizure medication are eligible to participate\n* Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib will be determined following review by the principal investigator\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded. Low-dose warfarin (=\\\u003C 1 mg\u002Fday) is permitted\n* Women who are currently lactating\n* History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors \"one after the other\" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Castration-Resistant Prostate Carcinoma","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","HER2-Positive Breast Carcinoma","Locally Advanced Breast Carcinoma","Locally Advanced Gastric Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Ovarian Carcinoma","Locally Advanced Pancreatic Carcinoma","Locally Advanced Prostate Carcinoma","Metastatic Breast Carcinoma","Metastatic Gastric Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Pancreatic Carcinoma","Metastatic Prostate Carcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Breast Carcinoma","Recurrent Gastric Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Pancreatic Carcinoma","Recurrent Prostate Carcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","RECRUITING","2026-06-18",{"date":60,"type":61},"2026-06-22","ACTUAL",{"date":63,"type":61},"2021-04-26",{"date":65,"type":20},"2026-12-01",{"name":67,"class":68},"National Cancer Institute (NCI)","NIH",4,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100604077","early-phase-1-effects-of-a-probiotic-intervention-on-the-gut-and-vaginal-microbiome-in-patients-with-advanced-or-recurrent-ovarian-cancer-undergoing-treatment-with-platinum-chemotherapy-100604077","NCT07144826","Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy","A Randomized, Double-Blind, Placebo Controlled, Study to Investigate Efficacy of a Probiotic Intervention on the Gut and Vaginal Microbiome of Ovarian Cancer Patients Undergoing Treatment With Platinum Chemotherapy","Inclusion Criteria:\n\n* Ability to understand and willingness to sign a written consent form. In patients who do not speak English, ability to have informed consent form translated in their native language and have their native language translator present for consenting process\n* Age \\> 18 years old\n* Patient with advanced (stage II, III or IV) or recurrent ovarian cancer who will receive platinum-based chemotherapy as standard of care (cisplatin, carboplatin containing regimens)\n* Agreeable to participate in all research activities defined in the study\n* Agreeable to not take any other probiotic and\u002For prebiotic supplements outside of study intervention during the study\n* Agreeable to not make significant changes to their diet throughout the course of the study\n* Patients with ileostomy, colostomy are permitted to participate\n\nExclusion Criteria:\n\n* Borderline ovarian tumors\n* Prior allergy or food intolerance to any probiotic product\n* History of chronic inflammation or active structural abnormality of the digestive tract (e.g., inflammatory bowel disease requiring medications, active duodenal or gastric ulcer, complete large or small bowel intestinal obstruction, active fistula)\n* Patients who do not meet laboratory parameters for platinum-based chemotherapy, including absolute neutrophil count (ANC) \\\u003C 1500\n* Known hypersensitivity to any component of study product (Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium butyricum and Bifidobacterium infantis, chicory inulin, magnesium stearate, grape food color, and silica)\n* Known hypersensitivity to \\> 4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: penicillin, piperacillin, tetracycline, amoxicillin, ampicillin\n* Known hypersensitivity to \\> 4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26\\^Trademark (TM): gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin","FEMALE",{"count":79,"type":20},161,[81],"EARLY_PHASE1","This clinical trial evaluates the effects a probiotic intervention has on the gut and vaginal microbiome in patients undergoing chemotherapy for ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Gut health is also known as the gut microbiome. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. Probiotics are dietary supplements containing live microorganisms that may help keep the gastrointestinal tract healthy. A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and oncologic outcomes.",[84,47,85,51,54],"Advanced Ovarian Carcinoma","Stage II Ovarian Cancer AJCC v8","2026-06-16",{"date":58,"type":61},{"date":89,"type":61},"2026-03-06",{"date":91,"type":20},"2027-07-09",{"name":93,"class":94},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":95},"100442316","phase-1-iacs-6274-with-or-without-bevacizumab-and-paclitaxel-for-the-treatment-of-advanced-solid-tumors-100442316","NCT05039801","IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors","A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 as Monotherapy and in Combination in Patients With Advanced Solid Tumors","Inclusion Criteria All Parts\n\n1. Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to participation in any study related activities.\n3. Histologically or cytologically confirmed advanced solid tumors, specifically:\n\n   Dose Escalation for Part A may include:\n\n   Patients with tumors harboring actionable KEAP1\u002FNFE2L2\u002FSTK11\u002FNF1 mutations Patients with low ASNS expression levels (HGSOC or endometrial cancer) Patients who had immunotherapy (IO) melanoma (Minimum treatment duration of prior PD-1 or PD-L1-containing regimen of 12 weeks \\[or equivalent of 2 response evaluations\\]).\n\n   Patients with post-platinum HNSCC Patients with chondrosarcoma Patients with ARID1A mutant clear cell ovarian cancer\n\n   Dose Escalation for Part B may include:\n\n   Confirmed recurrent high-grade non-mucinous ovarian cancer that is platinum-resistant, defined as disease relapse within a platinum-free interval (PFI, or the time elapsed from the last date of platinum dose until PD) of \\\u003C 6 months, and with less than 5 prior therapies\n\n   Dose Expansion for Part B limited to:\n\n   Confirmed recurrent high-grade non-mucinous ovarian cancer with low ASNS expression levels that is platinum-resistant, defined as disease relapse within a PFI of \\\u003C 6 months, and with less than 5 prior therapies.\n\n   Dose Escalation for Part C may include:\n\n   Patients with tumors harboring actionable KEAP1\u002FNFE2L2 mutations Patients with tumors harboring PIK3CA hotspot mutations, activating AKT mutations, and inactivating PTEN mutations (irrespective of KEAP1\u002FNFE2L2 mutations) Patients with low ASNS expression levels (HGSOC)\n\n   Dose Expansion for Part C limited to:\n\n   Patients with NSCLC with actionable KEAP1\u002FNFE2L2 mutations Patients with HGSOClow ASNS expression levels (irrespective of biomarker status for KEAP1\u002FNFE2L2)\n4. Patients must have received at least one line of therapy for advanced stage disease and be refractory or ineligible to available existing therapy(ies) known to provide clinical benefit for their condition.\n5. Prior treatment with chemotherapy, radiotherapy, immunotherapy or any investigational therapies must have been completed at least 3 weeks or at least five half lives, whichever is shorter, before the study drug administration, and all AEs (excluding alopecia and peripheral neuropathy) have either returned to ≤Grade 1 or stabilized. Patients with concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) are allowed.\n6. Fresh and\u002For archival tumor tissue from a biopsy obtained between the completion of the most recent line of treatment until study entry must be available for mutation and biomarker analysis. If available, archival tumor tissue from the time of initial diagnosis or the most recent biopsy (archival and\u002For fresh) will be collected. For ovarian cancer patients, a fresh biopsy must be collected in addition to archival tumor tissue. NOTE: No fresh tumor tissue will be required if a previous biopsy detected the selected mutations for each cohort. In all cases, procedures to obtain fresh tumor tissue should not put the patient at undue risk, and should only be performed if the risk is minimal (no greater than 2% risk of serious or severe complications).\n7. Patients must have at least 1 lesion (measurable and\u002For non-measurable) that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessments.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n9. Adequate organ function as indicated by the following laboratory values:\n\n   Absolute neutrophil count (ANC) ≥1.0×109\u002FL Platelets ≥100×109\u002FL Hemoglobin ≥9.0 g\u002FdL (\\>5.59 mmol\u002FL) Creatinine clearance (CrCl) \\>50 mL\u002Fmin. Actual body weight should be used for calculating creatinine clearance using the Cockroft Gault equation (except for patients with body mass index \\>30 kg\u002Fm2 when the lean body weight should be used, and without the need for chronic dialysis therapy).\n\n   Serum total bilirubin ≤1.5×ULN (with the exception of patients with known thalassemia minor mutations or Gilbert's syndrome: serum total bilirubin must be \\\u003C3×ULN in these patients) Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) ≤2.5×ULN or ≤5×ULN for patients with liver metastases)\n10. Adequate cardiac function with a left ventricular ejection fraction ≥50%\n11. Female patients of non childbearing potential, who are physiologically incapable of becoming pregnant, are eligible to enter and participate in the study if they:\n\n    have had a hysterectomy, OR have had a bilateral oophorectomy, OR have had a bilateral salpingectomy, OR is postmenopausal (total cessation of menses for ≥2 years, or follicle stimulating hormone ≥50 IU\u002FL).\n12. Female patients of childbearing potential, who are not post-menopausal or surgically sterile and intent to be sexually active with a non-sterile male partner, are required to use one form of highly effective contraception combined with a barrier method (male condom, female condom, cervical cap, diaphragm with spermicide, or contraceptive sponge with spermicide) of contraception starting before entering the study and until 4 weeks after the last dose of treatment.\n\n    Highly effective non-hormonal contraceptive methods that are acceptable include:\n\n    Total\u002Ftrue abstinence\\*\\*\\* for the total duration of the study treatment and for at least 1 month after the last dose of study treatment. Periodic abstinence using methods such as calendar ovulation, symptothermal, post ovulation methods, declaration of abstinence solely for the duration of a trial, or withdrawal are not acceptable methods of contraception.\n\n    Having a vasectomized sexual partner, who received post-vasectomy confirmation of azoospermia, combined with a barrier method as described above.\n\n    Bilateral tubal occlusion combined with a barrier method as described above. Intrauterine device with copper banded coils, combined with a barrier method as described above.\n\n    Highly effective hormonal contraceptive methods that are acceptable include:\n\n    Combined oral pill contraception (normal and low-dose oral pills, or progesterone-based oral pills using desogestrel) combined with a barrier method as described above. NOTE: cerazette is currently the only highly efficacious progesterone-based pill available.\n\n    Injection (e.g., medroxyprogesterone) combined with a barrier method as described above.\n\n    Patch (e.g., norelgestromin or ethinyl estradiol transdermal system) combined with a barrier method as described above.\n\n    Implants (etonorgestrel-releasing) combined with a barrier method as described above.\n\n    Intravaginal device (e.g., ethinyl estradiol- or etonogestrel-releasing) combined with a barrier method as described above.\n\n    Intrauterine system (levonorgestrel-releasing) combined with a barrier method as described above.\n\n    In addition to the to use one form of highly effective contraception combined with a barrier method, female patients of childbearing potential must have a negative serum pregnancy test at screening (within 7 days of the start of treatment) and must not be breastfeeding.\n13. Non-sterile men, who are not sexually abstinent and intend to be sexually active with a woman of childbearing potential, must use a condom from the start of the trial and until 16 weeks after the last dose of treatment, or must practice total abstinence\\*\\*\\* for the total duration of the study treatment and at least 3 months after the last dose of study treatment. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female partners of childbearing potential should consider the use of at least one contraception method describe above. If the female partner is pregnant, male participants should use a condom plus spermicide.\n\n    * Total\u002Ftrue abstinence is defined as a patient who refrains from any form of sexual intercourse, and this is in line with their usual and\u002For preferred lifestyle.\n\nExclusion Criteria All Parts\n\n1. Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder.\n2. Known primary central malignancy or symptomatic central nervous system metastasis(es).\n\n   Note: Patients with stable, previously treated brain metastases may participate if neurologic symptoms have resolved, patients have been off steroids (at least 7 days for Part A and Part B, and at least 4 weeks for Part C), and there is no evidence of disease progression by imaging for at least 2 weeks before the first dose of study treatment.\n3. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following cardiac conditions:\n\n   1. Any unstable cardiac arrhythmia within 6 months prior to enrolment\n   2. Prolongation of the Fridericia corrected QT (QTcF) interval defined as \\>450 ms for males and \\>470 ms for females\n   3. History of any of the following cardiovascular conditions within 6 months of enrolment:\n\n      * cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association.\n4. Major surgical intervention within 28 days before study drug administration, or an anticipated need for major surgery during the study.\n5. Significant acute or chronic infections.\n6. Any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n7. Treatment with strong cytochrome P450 subtype 3A4 (CYP3A4) inducers and inhibitors (including grapefruit juice) within 2 weeks of the first dose of study drug NOTE: patients must have stopped taking St. John's Wort 3 weeks prior to the start of treatment and stopped taking enzalutamide 4 weeks prior to the start of treatment.\n8. Treatment with strong CYP450 subtype 2D6 (CYP2D6) inhibitors or sensitive CYP3A4 substrates within 7 days of the first dose of study drug.\n9. Radiotherapy within 4 weeks prior to the start of study drug. Palliative radiotherapy for symptomatic control is acceptable if completed at least 2 weeks prior to study drug administration and no additional radiotherapy for the same lesion is planned.\n10. Underlying medical conditions (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases), for which in the investigator's opinion will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or AEs.\n11. History of allergic reactions attributed to compounds of similar chemical or biological composition to any of the compounds in the study.\n12. Known history of alcohol or drug abuse.\n13. Legal incapacity or limited legal capacity.\n14. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses (such as refractory nausea and vomiting, chronic gastrointestinal disease or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretionof IACS-6274 and capivasertib, which are oral agents.\n15. Patients unwilling to comply with protocol requirements related to the assigned part.\n16. Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n\nPart B Specific Exclusion Criteria (B1) Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, three or more features of partially controlled asthma).\n\n(B2) Patient has a known hypersensitivity to paclitaxel or bevacizumab components or excipients.\n\n(B3) Patient has a history of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.\n\n(B4) Patient has proteinuria as demonstrated by urine protein:creatinine ratio ≥1.0 at screening or urine dipstick for proteinuria ≥2 (patients discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate \\\u003C2 g of protein in 24 hours to be eligible).\n\n(B5) Patient is at increased bleeding risk due to concurrent conditions (e.g., major injuries or surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).\n\n(B6) Patient has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident \\[CVA\\]) within 6 months of enrollment. (B7) Patient has pre-existing peripheral neuropathy that is Grade ≥2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.\n\n(B8) Patient requires paracentesis 2 weeks prior to trial enrolment. Part C Specific Exclusion Criteria (C1) History of another primary malignancy, except for a malignancy treated with curative intent, with no known active disease ≥5 years before the first dose of treatment, with low potential risk for recurrence. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy.\n\n(C2) Patient has a known hypersensitivity to capivasertib components or any excipients of the product.\n\n(C3) Clinically significant abnormalities of glucose metabolism as defined by any of the following: Diagnosis of diabetes mellitus type I or II (irrespective of management), Glycosylated haemoglobin (HbA1c) \\>8% (64 mmol\u002Fmol) (C4) Patients with evidence of severe or uncontrolled systemic liver disease including severe hepatic impairment, or abnormal liver enzymes at screening (AST or ALT \\>2.5 x ULN; total bilirubin \\>1.5 x ULN).\n\n(C5) Patients with elevated alkaline phosphatase (ALP) can be enrolled if the abnormal value is due to the presence of bone metastasis, but liver function is considered adequate according to the principal investigator.\n\n(C6) Patients with persistent toxicities (Grade ≥2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment may be included after consultation with the sponsor and the study physician.\n\n(C7) Patients with spinal cord compression or leptomeningeal disease not requiring steroids for at least 4 weeks prior to start of study intervention.\n\n(C8) Patients with clinically significant cardiovascular disease including, but not limited to, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident \\[CVA\\]) within 6 months of enrollment. In addition, patients will be excluded based on the study physician's judgment of the following criteria:\n\n* Mean resting corrected QT interval \\>470ms, obtained from triplicate ECGs performed at screening.\n* Medical history significant for arrhythmia that is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation regardless of treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be included based on the study physician's judgment.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia of Grade ≥1, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relative, history of QT prolongation associated with other medications that required discontinuation of the medication.\n* Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association Grade ≥2.\n* Uncontrolled hypotension: SBP \\\u003C90 mmHg and\u002For DBP \\\u003C50 mmHg.\n* Cardiac ejection fraction outside institutional range of normal or \\\u003C50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n\n(C9) Patients with active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) are excluded.\n\n(C10) Patients with active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening are excluded.\n\nHuman immunodeficiency virus (HIV) positive patients with a viral load \\> 400 copies\u002FmL and a CD4+ T-cell count of \\\u003C350 cells\u002FuL or with a history of an acquired immunodeficiency syndrome (AIDS) opportunistic infection within the past 12 months are excluded. Patients with a higher viral load or lower CD4+ count (\\\u003C 350 cells\u002FuL) may be considered for eligibility if the patient has a potentially curable malignancy or for interventions in a later stage of development that have demonstrated prior activity with a given cancer.\n\nHIV-positive patients receiving antiretroviral therapies should be on established ART for at least four weeks before starting treatment to ensure that treatment is tolerated and that toxicities are not confused with investigational drug toxicities. HIV-positive patients receiving antiretroviral therapies that are strong CYP3A4\u002F5 inhibitors\u002F inducers or sensitive substrates of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib.\n\n(C12) Patients who are undergoing any concurrent anticancer treatment or any concomitant medication that may interfere with the study drugs according to local clinical guidelines are excluded.\n\n(C13) Patients who received palliative radiotherapy within 2 weeks prior to the start of study treatment; or radiotherapy to more than 30% of the bone marrow within 4 weeks before the start of study treatment are excluded.",{"count":104,"type":20},54,[106],"PHASE1","To find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied.",[109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,51,129,130,131,132,133,134,135,136,137,138,139,54,140,141,142,143,144],"Advanced Endometrial Carcinoma","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Malignant Solid Neoplasm","Advanced Melanoma","Advanced Ovarian Clear Cell Adenocarcinoma","Chondrosarcoma","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Recurrent Ovarian High Grade Serous Adenocarcinoma","Refractory Endometrial Carcinoma","Refractory Head and Neck Squamous Cell Carcinoma","Refractory Melanoma","Refractory Ovarian Clear Cell Adenocarcinoma","Refractory Ovarian High Grade Serous Adenocarcinoma","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","2026-05-29",{"date":147,"type":61},"2026-06-01",{"date":149,"type":61},"2021-09-30",{"date":151,"type":20},"2028-06-30",{"name":153,"class":94},"M.D. Anderson Cancer Center",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100360076","phase-1-talazoparib-and-radiation-therapy-in-treating-patients-with-locally-recurrent-gynecologic-cancers-100360076","NCT03968406","Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers","Phase I Study of Talazoparib in Combination With Radiation Therapy for Locally Recurrent Gynecologic Cancers","Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Histologically-confirmed recurrent ovarian, fallopian tube, primary peritoneal cancer, endometrial, vaginal, or cervical cancer in the abdomen and pelvis\n* Subjects with stage IV disease are eligible as long as disease elsewhere (other than the site(s) to receive radiation therapy \\[RT\\]) is undetectable or stable (\\>= 3 months) and immediate chemotherapy is not required. Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies at least three weeks prior to start of investigational therapy\n* Hemoglobin \\>= 10.0 g\u002FdL and no blood transfusions in the 28 days prior to entry\u002Frandomization (choose whichever is most applicable to the study) (within 28 days prior to administration of study treatment)\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* No features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) on peripheral blood smear (within 28 days prior to administration of study treatment)\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* Platelet count \\>= 100 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be =\\\u003C 5 x ULN (within 28 days prior to administration of study treatment)\n* Serum creatinine =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\n  * Note: If cannot fulfill ECOG 0-1, must fulfill inclusion criteria below (minimum life expectancy of \\>= 16 weeks)\n* Patients must have a life expectancy \\>= 16 weeks\n* Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Postmenopausal is defined as:\n\n  * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50, radiation-induced oophorectomy with last menses \\> 1 year ago, chemotherapy-induced menopause with \\> 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)\n* Patient of child-bearing potential is willing to adhere to using two forms of highly effective birth control. Condoms with spermicide and one of the following are acceptable: oral contraceptive or hormonal therapy or placement of an intrauterine device (IUD). Acceptable non-hormonal birth control methods include: total sexual abstinence, vasectomized sexual partner plus male condom, tubal occlusion plus male condom with spermicide, IUD plus male condom+spermicide. Acceptable hormonal methods include: etonogestrel implants (i.e. Implanon, Norplan), normal and low dose combined oral pills, norelgestromin\u002Fethinyl estradiol (EE) transdermal system, intravaginal device (i.e. EE and etonogestrel) or cerazette (desogestrel). All of these would need to be combined with male condom with spermicide\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* At least one lesion, not previously irradiated, that can be accurately measured at baseline as \\>= 10 mm in the longest diameter (except lymph nodes which must have short axis \\>= 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements\n* For inclusion in biomarker endpoint, patients must fulfill the following criterion:\n\n  * Provision of informed consent for tumor biopsies \\* If a patient declines to participate in tumor biopsies, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to that part\n\nExclusion Criteria:\n\n* Ascites, peritoneal carcinomatosis, hepatic metastases\n* Prior radiotherapy in the region of planned radiotherapy\n* Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy\n* Previous enrollment in the present study\n* Participation in another clinical study with an investigational product during the last 4 weeks\n* Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \\>= 5 years (will require discussion with study physician)\n* Patients receiving any systemic chemotherapy, radiotherapy\n* Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir\n* Concomitant use of known P-gp inhibitors (i.e. dronedarone, quinidine, ranolazine, verapamil, ketoconazole, itraconazole), P-glycoprotein (P-gp) inducers (i.e. rifampin, tipranavir, ritonavir), or breast cancer resistance protein (BCRP) inhibitors (i.e. elacridar \\[GF120918\\]) should be avoided. If patients are taking any P-gp inhibitors, P-gp inducers, or BRCP inhibitors, they will need to stop them prior to enrolment on the study\n* Persistent toxicities (\\>= Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade 2) with the exception of alopecia, caused by previous cancer therapy\n* Resting electrocardiogram (ECG) with corrected QT (QTc) \\> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia\n* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment\n* Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (CT) scan or any psychiatric disorder that prohibits obtaining informed consent\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Breast feeding women\n* Patients with a known hypersensitivity to talazoparib or any of the excipients of the product\n* Patients with uncontrolled seizures\n* Patients requiring pelvic and para-aortic radiotherapy (defined as levels L1\u002FT12)\n* Patients with isolated vaginal relapse (i.e. no disease in lymph nodes or else where in pelvis\u002Fabdomen)",{"count":162,"type":20},24,[106],"This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.",[166,167,168,169,47,170,171,172,173,54,174,140,175,176,177,141,178,142,179,180,181,143,182,144,183],"Malignant Female Reproductive System Neoplasm","Recurrent Cervical Carcinoma","Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Vaginal Carcinoma","Stage IV Cervical Cancer AJCC v8","Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Fallopian Tube Cancer AJCC v8","Stage IVA Primary Peritoneal Cancer AJCC v8","Stage IVA Vaginal Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Fallopian Tube Cancer AJCC v8","Stage IVB Primary Peritoneal Cancer AJCC v8","Stage IVB Vaginal Cancer AJCC v8","2026-03-10",{"date":186,"type":61},"2026-03-11",{"date":188,"type":61},"2019-09-26",{"date":190,"type":20},"2027-10-01",{"name":153,"class":94},2,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},"100406708","phase-3-minimally-invasive-surgery-after-neoadjuvant-chemotherapy-for-the-treatment-of-stage-iiic-iv-ovarian-primary-peritoneal-or-fallopian-tube-cancer-lance-trial-100406708","NCT04575935","Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial","Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitional carcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma or pathology consistent with high-grade mullerian carcinoma.\n* Patient is considered by treating physician to be a surgical candidate after completion of 3 to 4 cycles of platinum-based chemotherapy, or an investigational neoadjuvant regimen given according to protocol, with complete radiologic resolution of any disease outside the abdominal cavity. Pleural effusions are acceptable per the local PI's discretion.\n* Normalization of CA-125 according to individual participating center reference range (Note: Among patients with a normal CA-125 at initiation of therapy, the CA-125 cannot exceed 35 U\u002FmL at the completion of NACT prior to interval debulking surgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnostic laparoscopy prior to debulking surgery. a. For patients undergoing diagnostic laparoscopy, surgeon considers that optimal debulking is feasible either by MIS or laparotomy.\n* Timeframe of \\\u003C 6 weeks (42 days) from the last cycle of NACT to interval debulking surgery. Overall timeframe may be extended per MD Anderson PI discretion.\n* ECOG performance status 0-2\n* Signed informed consent and ability to comply with follow-up\n* Negative pregnancy test by blood or urine (within 14 days prior to surgery)\n* Disease free of other active malignancies in the previous five years, except basal and squamous cell carcinomas of the skin\n\nExclusion Criteria:\n\n* Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging (CT, PET-CT, or MRI) including but not limited to the following findings that may preclude minimally invasive resection per surgeon's assessment. • Failure of improvement of ascites during NACT (trace ascites is allowed) • Small bowel or gastric tumor involvement • Colon or rectal tumor involvement • Diaphragmatic tumor involvement • Splenic or hepatic surface or parenchymal tumor involvement • Mesenteric tumor involvement • Tumor infiltration of the lesser peritoneal sac\n* History of psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule\n* Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemed by participating institution's clinicians\n* Any other contraindication to MIS as assessed by the clinician",{"count":201,"type":20},580,[203],"PHASE3","This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and\u002For improving quality of life after surgery.",[84,206,207,208,209,210,211,212,213,214,215,216,217,218,136,219,173,54,174,177,141,178,181,143,182],"Fallopian Tube Clear Cell Adenocarcinoma","Fallopian Tube Endometrioid Tumor","Fallopian Tube Serous Neoplasm","Fallopian Tube Transitional Cell Carcinoma","Ovarian Clear Cell Adenocarcinoma","Ovarian Endometrioid Adenocarcinoma","Ovarian Serous Adenocarcinoma","Ovarian Transitional Cell Carcinoma","Primary Peritoneal Clear Cell Adenocarcinoma","Primary Peritoneal Endometrioid Adenocarcinoma","Primary Peritoneal Serous Adenocarcinoma","Primary Peritoneal Transitional Cell Carcinoma","Stage IIIC Fallopian Tube Cancer AJCC v8","Stage IIIC Primary Peritoneal Cancer AJCC v8","2026-03-03",{"date":222,"type":61},"2026-03-05",{"date":224,"type":61},"2020-08-05",{"date":226,"type":20},"2028-12-31",{"name":153,"class":94},19,{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":95},"100471195","early-phase-1-hyperthermic-intraperitoneal-chemotherapy-with-cisplatin-during-surgery-or-cisplatin-before-surgery-for-the-treatment-of-stage-iii-or-iv-ovarian-fallopian-tube-or-peritoneal-cancer-100471195","NCT05415709","Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer","Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III\u002FIV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.","Inclusion Criteria:\n\n* Ability to understand (English-speaking), and willingness to sign a written, informed consent\n* Age \\> 18 years old\n* Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by:\n\n  * Biopsy\u002Fhistology (either by interventional radiology or laparoscopy) OR\n  * Cytology; If diagnosis is based on cytology the following criteria must be met:\n\n    * Immunohistochemistry on the block from cytology to demonstrate Mullerian origin\n    * Presence of pelvic mass AND CA 125 \\> 200kU\u002FI AND CA125\u002FCEA ratio \\> 25 at initial diagnosis\n    * Omental cake or other metastases larger than 2 cm in the upper abdomen and\u002For regional lymph node metastasis irrespective of size (diagnosed by computed tomography \\[CT\\]\u002Fmagnetic resonance imaging \\[MRI\\], ultrasound, or laparoscopy)\n* Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon\n* Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery\n* Completion of three cycles of neoadjuvant chemotherapy (NACT) with standard therapy (carboplatin \\[area under the curve (AUC) 5-6\\] day \\[D\\]1 + paclitaxel \\[175 mg\u002Fm\\^2\\] D1 every 3 weeks)\n\n  * Following 3-4 cycles of NACT partial or complete response\n  * Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3\u002Fprior to surgery\n* Fit for major surgery, American Society of Anesthesiologists (ASA )1 or ASA 2\n* Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2\n* Serum creatinine \\\u003C 1.4 mg\u002FdL\n* Creatinine clearance \\> 60 ml\u002Fmin (Cockcroft-Gault formula)\n* White blood cell count \\> 3.5 x 10\\^9 cells\u002FL\n* Absolute neutrophil count \\> 1.5 kg\u002Ful\n* Platelets \\> 100,000\u002Ful\n* Total bilirubin within 1.5 x normal institutional limits\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x institutional upper limit of normal\n* For quality of life assessment, baseline questionnaires should be filled in before randomization\n\nExclusion Criteria:\n\n* History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* Low grade serious carcinoma of the ovary or borderline ovarian tumors\n* History or current diagnosis of inflammatory bowel disease\n* History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n* Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery and be replaced",{"count":237,"type":20},45,[81],"This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.",[241,242,243,211,244,212,215,216,245,51,246,247,130,248,249,132,250,133,251,134,252,218,136,219,173,54,174,177,141,178,181,143,182],"Fallopian Tube Endometrioid Adenocarcinoma","Fallopian Tube Mucinous Adenocarcinoma","Fallopian Tube Serous Adenocarcinoma","Ovarian Mucinous Adenocarcinoma","Stage III Fallopian Tube Cancer AJCC v8","Stage III Primary Peritoneal Cancer AJCC v8","Stage IIIA Fallopian Tube Cancer AJCC v8","Stage IIIA Primary Peritoneal Cancer AJCC v8","Stage IIIA1 Fallopian Tube Cancer AJCC v8","Stage IIIA2 Fallopian Tube Cancer AJCC v8","Stage IIIB Fallopian Tube Cancer AJCC v8","Stage IIIB Primary Peritoneal Cancer AJCC v8","2026-02-09",{"date":255,"type":61},"2026-02-11",{"date":257,"type":61},"2022-06-13",{"date":259,"type":20},"2026-12-31",{"name":93,"class":94},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":95},"100475056","phase-2-plx038-for-treatment-of-metastatic-platinum-resistant-ovarian-primary-peritoneal-and-fallopian-tube-cancer-100475056","NCT05465941","PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer","Phase II Clinical Trial of PLX038 in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years NOTE: Because no dosing or adverse event data are currently available on the use of PLX038 in patients \\\u003C 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials\n* Histological confirmed high grade serous ovarian cancer consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (NOTE: Any of these diseases are referred to in this protocol as \"ovarian cancer\")\n* Recurrent high grade serous ovarian cancer that was initially platinum sensitive (i.e., had at least one platinum-free interval of at least 6 months before progression) is now platinum resistant\n* No more than one prior line of therapy for platinum resistant disease. NOTE: Prior poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy is allowed\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Disease that is amenable to two biopsies\n* Life expectancy greater \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin \\>= 8.0 g\u002FdL (obtained =\\\u003C 28 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (obtained =\\\u003C 28 days prior to registration)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (obtained =\\\u003C 28 days prior to registration)\n* Total bilirubin \\>= 1.5 x upper limit of normal (ULN) (obtained =\\\u003C 28 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C 28 days prior to registration)\n* Calculated creatinine clearance \\>= 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained =\\\u003C 28 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n\nExclusion Criteria:\n\n* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Histology other than high grade serous carcinoma\n* Prior treatment restrictions\n\n  * Chemotherapy =\\\u003C 4 weeks prior to registration\n  * Immunotherapy =\\\u003C 4 weeks prior to registration\n  * Radiotherapy =\\\u003C 4 weeks prior to registration\n  * Any other investigational therapy =\\\u003C 4 weeks prior to registration\n* History of prior or concurrent malignancy =\\\u003C 2 years prior to registration\n\n  * Exceptions: If natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Myocardial infarction within 6 months of study entry\n  * New York Heart Association (NYHA) class III or IV heart failure\n  * Uncontrolled dysrhythmias or poorly controlled angina\n  * History of serious ventricular arrhythmia (ventricular tachycardia \\[VT\\] or ventricular fibrillation \\[VF\\]) and\u002For factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome)\n* Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, Exception: Patients should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class IIB or better Exception: Patients who have received prior doxorubicin (Doxil) are eligible if asymptomatic with QTc =\\\u003C 480msec (Fridericia) and NYHA class IIB or better\n* Known human immunodeficiency virus (HIV) Exception: Patients on effective anti-retroviral therapy with undetectable viral load =\\\u003C 6 months prior to registration are eligible for this trial\n* Known hepatitis\n\n  * Exception: For patients with evidence of chronic hepatitis B virus infection the HepB viral load must be undetectable on suppressive therapy, if indicated, to be eligible\n  * Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* Receiving any other investigational agent\n* History of clinically significant gastrointestinal bleeding, colitis, or gastrointestinal perforation\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (APTT) above the normal range (Exceptions: low dose deep vein thrombosis \\[DVT\\] or line prophylaxis allowed)\n* Known central nervous system (CNS) disease Exception: Patients with treated brain metastases are eligible if follow-up brain imaging after CNS directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determined that immediate CNS specific treatment is not required and is unlikely to be required during the 1st cycle of therapy\n* Known Gilbert's syndrome or homozygous for the UGT1A1\\*28 variant allele or other relevant alleles with severely reduced UGT1A1 activity\n* Patients who require treatment with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038",{"count":269,"type":20},43,[23],"This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[273,274,275,173,54,174],"Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Ovarian Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","2026-02-05",{"date":253,"type":61},{"date":279,"type":61},"2022-09-14",{"date":281,"type":20},"2031-12-31",{"name":283,"class":94},"Mayo Clinic",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":95},"100446356","phase-1-phase-i-study-of-tumor-treating-fields-ttf-in-combination-with-cabozantinib-or-with-pembrolizumab-and-nab-paclitaxel-in-patients-with-advanced-solid-tumors-involving-the-abdomen-or-thorax-100446356","NCT05092373","Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax","Inclusion Criteria:\n\n* Participants must have pathologically confirmed advanced\u002Fmetastatic solid cancer (hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian\u002Ffallopian, or endometrial\u002Fprimary peritoneal tumors) involving the abdomen or thorax, cannot tolerate standard therapy or have experienced tumor progression on standard therapy.\n* Age: ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\>3 months.\n* Normal bone marrow function, defined as absolute neutrophil count ≥1,000\u002FµL; platelets ≥75,000\u002FµL; hemoglobin ≥8 g\u002FdL.\n* Adequate hepatic function as defined by a total bilirubin level ≤1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's syndrome, and alanine aminotransferase (ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤2.5 x ULN (unless the patient has liver metastases: ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤5 x ULN).\n* Participants with HCC must have a Child Pugh status A, no clinically significant ascites (requiring pharmacological or interventional treatment), and no history (or increased risk) of esophageal\u002Fgastric bleeding, impaired wound healing, perforation or fistula.\n* Serum creatinine clearance ≥50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Measurable disease by RECIST or evaluable disease.\n* Contraception: Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months and who have not had a tubal ligation, hysterectomy, or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. Male participants must agree to use effective contraception or abstinence while on study.\n* Able to operate the TTF device independently or with the help of a caregiver.\n\nExclusion Criteria:\n\n* Participants must not receive prior anticancer therapy or radiation therapy within 2 weeks and must not undergo major surgery within 4 weeks prior to initiation of treatment on protocol. Participants who are already on cabozantinib and have progressive disease are allowed to transition to treatment with tumor treating fields and cabozantinib. Participants in both cohorts who already started treatments as standard of care (Cohort 1: Cabozantinib and Cohort 2: nab-paclitaxel and Pembrolizumab) are allowed to start on protocol within the first 2-3 weeks of treatment initiation. Palliative radiation therapy is allowed.\n* Participants must have recovered to Grade 0-1 toxicity from prior therapy.\n* Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by brain imaging for at least 4 weeks and the patient must have been off steroids for at least 2 weeks.\n* The patient has cardiac conditions as follows: uncontrolled: hypertension (blood pressure \\[BP\\] \\> 160\u002F100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association Class II or above), prior or current cardiomyopathy, uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly).\n* The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n* Concurrent malignancies are permitted if (A) they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or (B) with agreement from the Principal Investigator (PI), participants who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or (C) with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n* The patient is pregnant or breastfeeding.\n* History of hypersensitivity or contraindication to TTF.\n* Implanted pacemaker, defibrillator or other electrical medical devices.\n* The participant has a previously-identified allergy or hypersensitivity to cabozantinib, nab-paclitaxel, or pembrolizumab, medical adhesives or hydrogel or the patient has received prior cabozantinib and discontinued therapy due to unacceptable toxicity.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n* CABOZANTINIB COHORT ONLY: The patient has experienced clinically-significant hematemesis or hemoptysis of \\> 0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has a cavitating pulmonary lesion(s) or a pulmonary lesion abutting or encasing a major blood vessel.\n* CABOZANTINIB COHORT ONLY: The patient has received drugs used to control loss of bone mass within 4 weeks prior to the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) test results that are above (1.3X) the laboratory upper limit of normal.\n* CABOZANTINIB COHORT ONLY: The subject has a corrected QT interval (QTcF) \\> 450 ms for men or \\> 470 ms for women.\n* CABOZANTINIB COHORT ONLY: The patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or FXa inhibitors, and antiplatelet agents. Low-dose aspirin (≤ 81 mg\u002Fday), low dose warfarin (≤ 1mg\u002Fday), and prophylactic low molecular weight heparin (LMWH) are permitted.\n* CABOZANTINIB COHORT ONLY: Patients with encasement of a major artery or bowel by tumor are excluded.\n* CABOZANTINIB COHORT ONLY: The patient is unable to swallow capsules.\n* CABOZANTINIB COHORT ONLY: History of hypersensitivity or contraindication to cabozantinib.\n* ATEZOLIZUMAB-CONTAINING COHORT: Participants who have received prior immunotherapy, including prior anti-PD-1 or anti-PD-L1 therapies may participate: (A) only if their prior anti-PD-1 or anti-PDL1 monotherapy or combination therapy were NOT the last treatment prior to participation on this study. (B) Participants who had prior immunotherapies and experienced Grade 1-2 immune-related adverse event (irAE) must have documentation that their irAEs are Grade 1 or 0 using current Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and participants must be off steroid therapy and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 14 days from Cycle 1, Day 1. (C) Participants who experienced Grade 3 irAEs consisting of laboratory abnormalities that were asymptomatic and have now resolved to Grade 1 or 0 and participants who have been off steroid and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 30 days from Cycle 1, Day 1. Participants with prior irAE pneumonitis (\\>= Grade 2) should not be given atezolizumab.\n* ATEZOLIZUMAB-CONTAINING COHORT: Human immunodeficiency virus (HIV) infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics.\n* ATEZOLIZUMAB-CONTAINING COHORT: Has received a live vaccine within 30 days prior to first dose.\n* ATEZOLIZUMAB-CONTAINING COHORT: Active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.\n* ATEZOLIZUMAB-CONTAINING COHORT: Serious autoimmune disease at the discretion of the treating attending: Patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g. Wegener's Granulomatosis) are excluded from this study.\n* ATEZOLIZUMAB-CONTAINING COHORT: History of\u002For current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.",{"count":269,"type":20},[106],"This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.",[294,109,295,296,297,298,299,84,300,301,26,302,303,304,27,305,306,38,307,308,309,310,311,312,41,313,314,315,316,317,318,319,245,320,51,246,321,129,247,322,130,248,131,249,132,250,133,251,323,134,252,135,218,136,219,137,138,139,173,324,54,174,325,140,177,326,141,178,142,181,327,143,182,144],"Advanced Breast Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Malignant Abdominal Neoplasm","Advanced Malignant Female Reproductive System Neoplasm","Advanced Malignant Thoracic Neoplasm","Advanced Primary Peritoneal Carcinoma","Advanced Renal Cell Carcinoma","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Malignant Abdominal Neoplasm","Malignant Solid Neoplasm","Metastatic Endometrial Carcinoma","Metastatic Fallopian Tube Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Abdominal Neoplasm","Metastatic Malignant Female Reproductive System Neoplasm","Metastatic Malignant Thoracic Neoplasm","Metastatic Primary Peritoneal Carcinoma","Metastatic Renal Cell Carcinoma","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","2026-01-13",{"date":330,"type":61},"2026-01-14",{"date":332,"type":61},"2022-04-29",{"date":334,"type":20},"2026-09-01",{"name":153,"class":94},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":95},"100581853","an-automated-personalized-physical-activity-intervention-to-improve-immune-function-and-clinical-outcomes-in-stage-ii-iv-ovarian-primary-peritoneal-or-fallopian-tube-cancer-and-newly-diagnosed-endometrial-cancer-life-on-the-go-3-study-100581853","NCT06855706","An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study","Life on the Go 3: A Randomized Controlled Trial of Automated, Personalized Physical Activity Intervention Using Wearable Devices to Improve Immune Function and Clinical Outcomes in Ovarian and Endometrial Cancer Patients","Inclusion Criteria:\n\n* Age ≥ 18 years old on day of signing informed consent\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participant must satisfy one of the following conditions:\n\n  * Have a clinically suspected or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer by clinical presentation and elevated CA-125 and may be awaiting staging surgery or tumor tissue biopsy followed by neoadjuvant chemotherapy. Inclusion of clinically suspected ovarian cancer cases is because we want to capture data starting from the earliest point of the diagnostic pathway and before definitive staging surgery. This allows us to assess the impact of physical activity and the feasibility of wearable device monitoring as patients transition into neoadjuvant chemotherapy and potential surgery\n  * Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any histology accepted). Inclusion of recurrent ovarian cancer cases is because ovarian cancer often recurs, and understanding physical activity patterns and interventions in patients experiencing recurrence is critical for comprehensive insights. This ensures the study includes the continuum of disease management beyond initial diagnosis\n  * Have pre-operative biopsy-proven endometrial cancer (endometrioid, serous, mucinous, or clear cell, poorly differentiated) with plans for surgical resection using a minimally invasive approach or medical management with chemotherapy combination, hormonal treatment or radiation. Inclusion of biopsy-proven endometrial cancer cases but not clinically suspected or recurrent cases is because we are focusing on confirmed, newly diagnosed patients who will undergo surgical resection or medical management\n* willing to wear the activity tracking device for at least 70% of their waking hours each day (11 hours\u002Fday) throughout the 6-month study period\n* under the care of Roswell Park Comprehensive Cancer Center during the study period, which includes one or more of the following:\n\n  * Receiving cancer treatment at Roswell Park Comprehensive Cancer Center\n  * Undergoing surgery at Roswell Park Comprehensive Cancer Center\n  * Participating in surveillance visits at Roswell Park Comprehensive Cancer Center\n  * Receiving adjuvant treatment at an outside facility but returning to Roswell Park Comprehensive Cancer Center for periodic consultation visits and agreeing to comply with all study procedures, including data sharing from external providers\n* willing to participate in questionnaires and blood and stool collection throughout the study for translational research purposes\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n* Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study (e.g., Fitbit Sense 2 and CGM applications)\n\n  * NOTE: Patients who are already achieving or exceeding the goal of 150 minutes of physical activity per week are eligible for this study. This inclusion is intentional, as the study aims to evaluate the full spectrum of physical activity levels-both baseline activity and changes over time-and their relationship with clinical outcomes, metabolic measures (e.g., glucose levels), inflammation, and physical function\n\nExclusion Criteria:\n\n* serious psychiatric illness that is not currently stabilized, including but not limited to:\n\n  * Schizophrenia or other psychotic disorders\n  * Bipolar disorder\n  * Sever major depressive disorder\n  * Severe personality disorders diagnosed by a qualified mental health professional\n  * Recent suicide attempt or psychiatric hospitalization within the previous 12 months\n* Life expectancy of less than 12 months, as determined by the Investigator based on clinical judgment and available prognostic tools\n* history of other invasive malignancies within the last two years, except for:\n\n  * Non-melanoma skin cancer\n  * In situ cervical cancer\n* resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements\n* systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of seated rest, confirmed on two separate measurements\n* Unstable angina or myocardial infarction within the past 3 months.\n\n  * Unstable Angina: Chest pain at rest or chest pain of increasing frequency, severity, or duration that requires medical attention\n  * Myocardial Infarction: Heart attack diagnosed by a medical professional\n* Pregnant or nursing participants will be excluded, as confirmed via urine test during screening procedures.\n* unwilling or unable to follow the protocol requirements, including but not limited to:\n\n  * Cognitive impairment that affects the ability to provide informed consent or comply with study procedures\n  * Language barriers without access to adequate translation services\n  * Lack of access to necessary technology (e.g., smartphones compatible with study devices)\n  * Other factors that would prevent adherence to study protocols\n* Any condition which, in the Investigator's opinion, makes the patient unsuitable for participation in the study or may interfere with the patient's ability to comply with the study requirements or the safety of the patient. Conditions may include, but are not limited to:\n\n  * Severe pulmonary disease\n  * Uncontrolled metabolic disorders\n  * Other significant medical conditions that pose a risk during increased physical activity\n* Participants who do not provide a valid cell phone number or do not consent to receive SMS messages from Fitabase for motivational and compliance monitoring purposes will be excluded from the study.",{"count":344,"type":20},120,[346],"NA","This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases. In fact, increased levels of physical activity have been shown to decrease the risk of some cancers as well as increase overall survival in some cancers. Currently, standard of care guidelines include participation in at least 150 minutes of moderate exercise weekly. An automated personalized physical activity intervention may increase physical activity, enhance quality of life, and improve physical function and daily living activities compared to standard recommendations in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer. This trial also evaluates the impact of physical activity on the gut microbiome and immune function. The microbiome is the collection of tiny organisms, like bacteria, that live in and on the body, especially places like the gut. These microorganisms play an important role in health. Information gathered from this study may help understand how the gut microbiome and physical activity influences the immune system in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer.",[349,169,47,170,350,85,351,245,51,246,173,54,174],"Endometrial Carcinoma","Stage II Fallopian Tube Cancer AJCC v8","Stage II Primary Peritoneal Cancer AJCC v8","2026-01-02",{"date":354,"type":61},"2026-01-06",{"date":356,"type":61},"2025-06-04",{"date":358,"type":20},"2028-04-30",{"name":360,"class":94},"Roswell Park Cancer Institute",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100387804","phase-1-pipac-for-the-treatment-of-peritoneal-carcinomatosis-in-patients-with-ovarian-uterine-appendiceal-colorectal-or-gastric-cancer-100387804","NCT04329494","PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer","Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC\n* Prior IP chemotherapy is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3\n* Platelets \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 9 g\u002Fdl\n* Serum total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to have chronic liver disease (hepatitis) in which case AST and ALT must be =\\\u003C 5 x ULN\n* Alkaline phosphatase =\\\u003C 2 x ULN\n* Serum creatinine (sCr) =\\\u003C 1.5 x ULN, or creatinine clearance (Ccr) \\>= 40 ml\u002Fmin as calculated by the Cockcroft-Gault formula\n* No contraindications for a laparoscopy\n* The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy\n* Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is define as:\n\n  * Amenorrhea \\>= 12 consecutive months without another cause or\n  * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL\n  * Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential\n* INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:\n\n  * PIPAC access is feasible\n  * There is room for aerosol therapy\n  * There is no evidence of impending bowel obstruction\n  * =\\\u003C 5 L of ascites\n  * Not a candidate for cytoreduction and HIPEC\n\nExclusion Criteria:\n\n* Gastric and colorectal\u002Fappendiceal:\n\n  * Extra-peritoneal metastatic disease\n* Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones\n* Arm 2 (colorectal\u002Fappendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency\n* Arm 2 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds\n* Arm 2 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 2 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 2 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 2 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 2 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 2 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 2 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 2 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 2 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 2 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 2 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Progression on first- AND second-line systemic therapy\n* Arm 3 (colorectal\u002Fappendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Intolerance to prior 5-FU at 2400mg\u002Fm\\^2 IV every 2 weeks or to irinotecan at 180mg\u002Fm\\^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of \\> 1 week due to toxicity\n* Arm 3 (colorectal\u002Fappendiceal): Known DPD deficiency\n* Arm 3 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 3 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 3 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 3 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 3 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 3 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 3 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 3 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 3 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 3 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 3 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy",{"count":369,"type":20},49,[106],"This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and\u002For to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.",[30,373,374,375,376,377,39,378,40,41,379,380,381,382,383,54,140,384,385,141,142,386,387,143,144,388,389],"Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Malignant Uterine Neoplasm","Metastatic Appendix Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Peritoneum","Pathologic Stage IV Gastric Cancer AJCC v8","Peritoneal Carcinomatosis","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Stage IV Appendix Carcinoma AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IVA Appendix Carcinoma AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVB Appendix Carcinoma AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVC Appendix Carcinoma AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2025-12-03",{"date":392,"type":61},"2025-12-10",{"date":394,"type":61},"2020-08-21",{"date":396,"type":20},"2028-01-05",{"name":398,"class":94},"City of Hope Medical Center",3,{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":77,"minAge":407,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":410,"phases":4,"briefSummary":411,"conditions":412,"keywords":419,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":439},"100423474","developing-a-test-of-uterine-lavage-for-the-detection-of-ovarian-cancer-100423474","NCT04794322","Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer","Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study","Inclusion Criteria:\n\n* Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)\n* Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian\u002Ffallopian tube cancer\n* Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy\n\nExclusion Criteria:\n\n* Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer\n* Inability to provide informed consent\n* Age less than 30 years\n* Inability to obtain the minimum amount of blood\n* Inability to obtain the minimum amount of uterine lavage sample\n* At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm\u002FdL)\n* Prior history of known ovarian or endometrial cancer\n* Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin\n* History of untreated high-grade cervical dysplasia (CIN3)\n* History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.\n* Currently pregnant\n* Known Lynch syndrome","30 Years",{"count":409,"type":20},250,"OBSERVATIONAL","The study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine whether the participant had ovarian cancer or a benign disease of the ovaries. The tests of the washings and the blood will be examined to see how much the participants with ovarian cancer can be separated from the participants with a benign ovarian disease by the tests. Small amounts from the washing and the blood samples will be sent to four sites for analysis.\n\nStatistical analyses of these data will compare tumor DNA found in the washing of the uterus with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find tests that are mostly positive for cases of ovarian cancer and mostly negative for patients with benign disease. It is hoped that if the tests work for participants with symptoms of the disease that these tests will also work when testing women who have no symptoms. A new study would be needed to see if the tests worked in this situation. If the tests work, this could lead to increasing the number of cases detected in early stage disease and decreasing the number of cases detected in late stage disease. If this change in late stage is large, it will likely reduce deaths due to ovarian cancer.",[413,414,415,416,417,418,51,130,132,133,134,136,54,141,143],"Ovarian Neoplasms","Ovarian Epithelial Carcinoma","Fallopian Tube Neoplasms","High Grade Ovarian Serous Adenocarcinoma","Stage I Ovarian Cancer","Stage II Ovarian Cancer",[420,421,422,423,424,425,426,427,428,429],"Uterine Lavage","Tumor DNA","Serum proteins","Ovarian neoplasms","Ovarian epithelial carcinoma","Ovarian cancer","Ovarian epithelial cancer","Neoplasms","Ovarian diseases","Early detection","2025-09-10",{"date":432,"type":61},"2025-09-16",{"date":434,"type":61},"2020-04-13",{"date":436,"type":20},"2028-08-31",{"name":438,"class":94},"Massachusetts General Hospital",6,{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":21,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":478,"leadSponsor":480,"locationsCount":95},"100495576","phase-2-cpi-613-devimistat-in-combination-with-hydroxychloroquine-and-5-fluorouracil-or-gemcitabine-in-treating-patients-with-advanced-chemorefractory-solid-tumors-100495576","NCT05733000","CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors","Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers","Inclusion Criteria:\n\n* Patients must have histologically confirmed cancer for which standard-of-care curative measures are no longer effective or be intolerant to those agents. Patients in cohort 1 must have colorectal cancer. Patients in cohort 2 must have pancreatic cancer. Patients in cohort 3 may have any of the following cancers:\n\n  * Biliary\n  * Gastroesophageal\n  * Urothelial\n  * Ovarian\n  * Non-small cell lung (adenocarcinoma only)\n* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 disease.\n* Patients must have radiographic documentation of metastatic disease with imaging within =\\\u003C 6 weeks prior to registration.\n* Patients must be age \\>= 18 years.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Performance Status of 2 will be allowed with approval from principle investigator (PI) on a case-by case basis.\n\n  * Note: Performance status of 2 will be allowed with approval from PI on a case-by case basis. Documentation of PI approval in these cases will be stored with inclusion\u002Fexclusion signed checklist for patient and\u002For in patient's shadow chart.\n* Patients must have exhausted all available molecularly targeted therapies (e.g., anti-PD-1\u002Fanti-PD-L1 agents where indicated).\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (within the last 14 days of screening)\n* Hemoglobin (Hgb) \\>= 9 g\u002FdL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \\>= 7 days from transfusion).\n* Platelets (PLT) \\>= 100,000\u002FmcL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \\>= 7 days from transfusion).\n* INR (international normalized ratio) =\\\u003C 1.6 (within the last 14 days of screening) (unless receiving anticoagulation therapy) If receiving anticoagulant: INR =\\\u003C 3.0 and no active bleeding, (i.e., no bleeding within 14 days prior to first dose of study therapy).\n* Total bilirubin =\\\u003C1.5 x Institutional upper limit of normal (ULN) (within the last 14 days of screening)\n\n  * Note: Patients with Gilbert's Syndrome are exempt. Patients with liver metastases with no significant bilirubin obstruction may have a total bilirubin level of =\\\u003C 2.0 mg\u002FdL.\n* Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) =\\\u003C 2.5 x institutional ULN (within the last 14 days of screening)\n\n  * Note: If liver metastases are present, then =\\\u003C 5 x ULN is allowed.\n* Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) =\\\u003C 2.5 x institutional ULN (within the last 14 days of screening)\n\n  * Note: If liver metastases are present, then =\\\u003C 5 x ULN is allowed.\n* Serum albumin \\> 3.0 g\u002FdL (within the last 14 days of screening)\n* Creatinine =\\\u003C 1.5 x ULN OR glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (within the last 14 days of screening)\n\n  * eGFR is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation\n* The effects of combination treatment of CPI-613, 5-FU, gemcitabine, and HCQ on the developing human fetus are unknown. For this reason and because antineoplastic agents as well as other therapeutic agents used in this trial are known to be teratogenic, patients of child-bearing potential (POCBP) regardless of gender must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 180 days following completion of therapy. Patients who can impregnate their partners regardless of gender must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 180 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.\n\n  * Note: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n  * Note: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative pregnancy test prior to registration on study.\n\n  * Note: If negative pregnancy test result is \\>7 days from first dose of study treatment it must be repeated at time of first dose of study treatment (with any of the four drugs used in this study).\n* For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment, must have an undetectable HCV viral load. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Patients must be class 2B or better.\n\n  * Note: Patients with pacemakers where corrected QT interval (QTc) is not a reliable measure will require an evaluation by a cardiologist to exclude co-existing cardiac conditions which would prohibit safe participation in the study.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document for the duration of the entirety of the study.\n* Patients must be reliable, willing to make themselves available for the duration of the entire study and willing to follow screening procedures.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1).\n\n  * Note: Patients who experience adverse events of alopecia and peripheral neuropathy that have not recovered are eligible; patients with any lab abnormality that is above grade 1 related to previous therapy found to be not clinically significant will also be eligible.\n* Patients with symptomatic brain metastases currently using corticosteroids.\n\n  * Note: Patients with brain metastases who are asymptomatic and off corticosteroids for at least one week are eligible.\n* Patients with severe obstructive pulmonary disease or interstitial lung disease.\n* Patients with a history of myocardial infarction that is \\\u003C90 days prior to registration.\n* Patients using concomitant medications that prolong the QT\u002FQTc intervals. For example, patients receiving amiodarone. Using amiodarone together with hydroxychloroquine can increase the risk of long QT syndrome that although rare, may be serious, and potentially life-threatening.\n* Patients with a history of additional risk factors for drug-induced QT prolongation or Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT syndrome).\n* Patients with major surgery or significant traumatic injury =\\\u003C 21 days prior to registration.\n* Patients receiving treatment with low dose chemotherapy concurrent with radiation =\\\u003C 21 days prior to registration.\n\nOR patients who have had chemotherapy or radiotherapy =\\\u003C 21 days (42 days for nitrosoureas or mitomycin C) prior to registration.\n\n* Note: Palliative radiation before and during study participation is permissible providing it is not to a target lesion.\n\n  * Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\n* Ongoing or active infection requiring systemic treatment.\n* Clinically significant complications such as perforation, gastrointestinal bleeding, or diverticulitis within 42 days prior to registration.\n* Symptomatic congestive heart failure; symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction.\n* Unstable angina pectoris.\n* Unstable cardiac arrhythmia.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active substance abuse.\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.\n\n  * Patients who are pregnant or nursing.\n  * Patients with Fridericia-corrected QT interval (QTcF) \\> 470 msec (female) or \\> 450 (male), or history of congenital long QT syndrome. Any electrocardiogram (ECG) abnormality that in the opinion of the investigator would preclude safe participation in the study.\n  * Patients who have pre-existing retinopathy of the eye.\n  * Patients who are unable to swallow or retain and absorb oral medication\n  * Patients with known hypersensitivity to any of the following: CPI or its inactive components, 4-aminoquinoline compounds, or quinine.\n  * Patients with poorly controlled diabetes mellitus (glycosylated hemoglobin (HbA1c) of \\> 7%, pre-prandial capillary plasma glucose \\> 130mg\u002Fdl, and peak postprandial capillary plasma glucose of \\> 180mg\u002Fdl).",{"count":448,"type":20},94,[23],"This phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.",[452,453,454,455,111,84,456,457,458,459,460,377,461,462,41,42,463,464,465,466,467,468,469,470,50,471,472,51,52,383,473,54,55],"Advanced Biliary Tract Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Advanced Lung Adenocarcinoma","Advanced Pancreatic Carcinoma","Advanced Urothelial Carcinoma","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Biliary Tract Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Lung Adenocarcinoma","Metastatic Urothelial Carcinoma","Refractory Biliary Tract Carcinoma","Refractory Colorectal Carcinoma","Refractory Gastroesophageal Junction Adenocarcinoma","Refractory Lung Adenocarcinoma","Refractory Ovarian Carcinoma","Refractory Pancreatic Carcinoma","Refractory Urothelial Carcinoma","Stage III Colorectal Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","2023-03-08",{"date":476,"type":61},"2023-03-10",{"date":474,"type":61},{"date":479,"type":20},"2030-03-04",{"name":481,"class":94},"Northwestern University"]