[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"platinum-resistant-primary-peritoneal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:platinum-resistant-primary-peritoneal-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,73,105,134,158],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100480600","phase-2-vismodegib-combined-with-atezolizumab-in-platinum-resistant-ovarian-fallopian-tube-and-primary-peritoneal-cancer-100480600",false,"NCT05538091","Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer","Phase II Clinical Trial Combining the Hedgehog Inhibitor Vismodegib With the PD-L1 Inhibitor Atezolizumab in Patients With Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Ability to comply with the study protocol, in the investigator's judgment\n* Histologically or cytologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer\n* Platinum status, defined by disease progression during or following treatment with platinum-based chemotherapy within 6 months of completing therapy\n* Measurable or non-measurable but evaluable disease per RECIST v1.1 {Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.}\n* Availability of a representative tumor specimen for exploratory biomarker research will be required for 12 patients (see Section 5.4.5 for information on tumor specimens)\n* ECOG Performance Status of 0-1\n* Life expectancy ≥ 3 months\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ≥ 1.5 ⋅ 109\u002FL (1500\u002FμL) without granulocyte colony-stimulating factor support; Lymphocyte count ≥ 0.5 ⋅ 109\u002FL (500\u002FμL); Platelet count ≥ 100 ⋅ 109\u002FL (100,000\u002FμL) without transfusion; Hemoglobin ≥ 80 g\u002FL (8 g\u002FdL) (Patients may be transfused to meet this criterion.)\n\n  * AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 ⋅ upper limit of normal (ULN), with the following exceptions:\n\n    * Patients with documented liver metastases: AST and ALT ≤ 5 ⋅ ULN\n    * Patients with documented liver or bone metastases: ALP ≤ 5 ⋅ ULN\n  * Serum bilirubin ≤ 1.5 ⋅ ULN with the following exception:\n\n    * Patients with known Gilbert disease: serum bilirubin ≤ 3 ⋅ ULN\n  * Serum creatinine ≤ 1.5 ⋅ ULN\n  * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n  * For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 ⋅ ULN\n  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible if they are stable on anti-retroviral therapy, have a CD4 count \\> 200, and have an undetectable viral load.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 24 months after the final dose of vismodegib. Women must refrain from donating eggs during this same period.\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n\nExclusion Criteria:\n\n* Inability or unwillingness to swallow capsules\n* Inability or unwillingness to comply with study procedures\n* History of leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n  o Patients with indwelling catheters (e.g., PleurX→) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 9) for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover \\\u003C 10% of body surface area\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted).\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than ovarian cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n\n  * Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.\n  * Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the vismodegib formulation\n* Agreement not to donate blood or blood products during the study and for 24 months after discontinuation of vismodegib.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and for 24 months after the final dose of vismodegib.\n\n  * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.","FEMALE","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This trial will treat patients with platinum resistant ovarian, fallopian tube or primary peritoneal cancer as defined by a progression free interval within six months of completion of most recent platinum-based treatment with a combination of vismodegib and atezolizumab. Despite recent improvements in treatment of ovarian cancer with the introduction of PARP inhibitors, response rates to therapy in the platinum resistant setting remain dismal with response rates of only 10-20% reported for single agent cytotoxic therapies. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.",[26,27,28,29],"Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","PARP Inhibitor","Hedgehog Inhibitor","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":34},"2023-05-15",{"date":38,"type":20},"2032-09-30",{"name":40,"class":41},"Ronald Buckanovich","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100366775","phase-2-onc201-plus-weekly-paclitaxel-in-patients-with-platinum-refractory-or-resistant-ovarian-cancer-100366775","NCT04055649","ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer","Phase II Study of ONC201 Plus Weekly Paclitaxel in Patients With Platinum-Resistant Refractory or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Progressed within 6 months of completing at least 1 cycle of last platinum containing regimen. Patients with refractory disease (progression during platinum-containing therapy) are eligible. This includes both adjuvant therapy and in the recurrent setting.\n* No more than 4 prior treatment regimens defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy in the platinum resistant setting and total of 7 prior regimens in all settings will be allowed. Prior maintenance therapy with biologic or targeted agent does NOT count as a treatment regimen (e.g. Maintenance bevacizumab, Parpi, or immunotherapy).\n* At least one measurable lesion according to RECIST v1.1.\n* For the eight patients enrolled for PK\u002FPD. Availability of tissue from carcinoma. For most patients this will be archival tissue. If there is no archival tissue available, biopsy of lesion MUST be performed prior to initiation of therapy. Lesions must be available for biopsy as well in these patients.\n* Any prior palliative radiation therapy must be completed at least 7 days prior to start of study treatment and patients must have recovered from any acute adverse effects prior to start of study treatment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n* Female patients who are not of childbearing potential and fertile female patients of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to start of study treatment.\n* Patients must have adequate (at baseline):\n\n  1. Bone marrow function: Absolute neutrophil count (ANC) ≥1,500\u002FµL. Platelets\n\n     ≥100,000\u002FµL and hemoglobin \\> 8.0 gm\u002FdL, transfusion allowed up to 1 week prior to maintain Hgb \\>8.\n  2. Renal function: Calculated creatinine clearance (CrCl) ≥35 mL\u002Fmin\u002F1.73 mm2\n  3. Hepatic function: Bilirubin less than or equal to 1.5 x ULN; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 x ULN. AP, AST and ALT less than or equal to 5 x ULN is acceptable if patient has known hepatic metastasis\n\nExclusion Criteria:\n\n* Use of a study drug (approved or investigational drug therapy) ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of current study treatment is required.\n* Major surgical procedures ≤21 days of beginning study treatment, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement, ureteral stent placement, percutaneous nephrostomy tube placement.\n* No other (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy \\[except for palliative local radiotherapy\\]), biological therapy or other novel agent is to be permitted while the patient is receiving study medications\n* Grade \\>1 toxicity from prior therapy (except alopecia or anorexia or above hematologic criteria) unless controlled by medications.\n* Inability to swallow oral medication. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN) on this trial.\n* Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression after treatment for at least 4 weeks (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrollment.\n* Patient has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 1 week prior to Day 1 of dosing and withheld throughout the study until 1 weeks after the last dose of study drug.\n* Any known hypersensitivity or contraindication to the components of study treatment\n* Pregnant or lactating\n* Serious active infection at the time of enrollment, or another serious underlying medical condition at discretion of the enrolling physician that would impair the ability of the patient to receive study treatment. HIV or other immunodeficiency disease that is well controlled and that does not impact baseline lab values (i.e. outside of above noted parameters for inclusion) are NOT considered exclusion criteria.\n* Presence of other active cancers other than ovarian cancer except those that do not require active therapy (i.e. on surveillance) and known non-invasive cancers and in situ cancers (e.g. non-melanoma skin cancers).\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.",{"count":51,"type":20},62,[23],"This phase II trial studies the side effects of ONC201 and paclitaxel and how well they work in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent), or that does not respond to treatment (refractory). ONC201 is the first in its class of drugs that antagonize some specific cell receptors on cancer cells, leading to their destruction. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ONC201 and paclitaxel may work better in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel alone.",[55,26,56,27,57,58,59,60,61,62],"Malignant Ovarian Epithelial Tumor","Platinum-Resistant Ovarian Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Refractory Fallopian Tube Carcinoma","Refractory Ovarian Carcinoma","Refractory Primary Peritoneal Carcinoma","2026-06-15",{"date":65,"type":34},"2026-06-17",{"date":67,"type":34},"2020-01-21",{"date":69,"type":20},"2027-05-28",{"name":71,"class":41},"Ira Winer",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100572213","phase-2-a-study-of-lorigerlimab-in-participants-with-advanced-solid-tumors-100572213","NCT06730347","A Study of Lorigerlimab in Participants With Advanced Solid Tumors","A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR\n* Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.\n* Persistent or recurrent disease with documented disease progression.\n* Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.\n* Participants with CCGC must have received at least 1 prior line of therapy for CCGC.\n* Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.\n* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.\n* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.\n* Participants have acceptable physical condition and laboratory values.\n* Participants of childbearing potential must agree to use highly effective methods of birth control.\n* Participants must not be pregnant, planning to be pregnant, or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.\n* Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1\u002FPD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.\n* Active brain metastases or leptomeningeal metastases.\n* Prior stem cell, tissue, or solid organ transplant.\n* Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.\n* Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.",{"count":81,"type":20},80,[23],"Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.\n\nParticipants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends.\n\nParticipants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.",[85,26,27,86,87,88,89,90,91,92,93],"Platinum-resistant Ovarian Cancer","Clear Cell Adenocarcinoma of Ovary","Clear Cell Adenocarcinoma of Vulva","Clear Cell Adenocarcinoma of Vagina","Clear Cell Adenocarcinoma of Cervix","Clear Cell Adenocarcinoma of Uterus","Clear Cell Adenocarcinoma of Fallopian Tube","Clear Cell Adenocarcinoma of Peritoneum","Endometrial Cancer","2026-05-29",{"date":96,"type":34},"2026-06-02",{"date":98,"type":34},"2025-05-01",{"date":100,"type":20},"2027-12",{"name":102,"class":103},"MacroGenics","INDUSTRY",16,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":42},"100553204","phase-1-muc1-activated-t-cells-for-the-treatment-of-relapsed-and-resistant-ovarian-cancer-100553204","NCT06483048","MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer","Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer\n* PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET\u002FCT\n\n  * Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler\n* PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1\u002F2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring \\\u003C 183 days after the last dose of platinum-based chemotherapy:\n\n  * Development of measurable disease (per RECIST 1.1)\n  * Progression of radiographic disease (per RECIST 1.1)\n  * Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits \\[WNL\\] at the completion of platinum-based chemotherapy)\n  * Increase in CA-125 level to ≥ 2 x nadir (if nadir \\> ULN)\n  * If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval\n* PRE-REGISTRATION: Provide written informed consent\n* PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma\n* REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study\n* REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months\n* REGISTRATION: Willingness and ability to provide written informed consent\n* REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study\n* REGISTRATION: Willing to undergo leukapheresis for blood component collection\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Lymphocyte count ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (performed ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 30,000\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 2.0 mg\u002FdL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis \\[DVT\\]\u002Fpulmonary embolism \\[PE\\] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)\n* REGISTRATION: Baseline oxygen saturation ≥ 90% on room air\n* REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration\n\nExclusion Criteria:\n\n* Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for \\> 30 days, and not requiring steroid therapy for \\> 14 days\n* Prior treatment targeting MUC1\n* Subjects with known plasma cell leukemia (PCL)\n* Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and\u002For teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate birth control measures\n* History of myocardial infarction ≤ 6 months prior to registration, and\u002For congestive heart failure requiring ongoing treatment such as medications and\u002For an implanted defibrillator to control life-threatening arrhythmias\n* Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.\n* Uncontrolled concurrent illness including, but not limited to:\n\n  * Inability to clear an ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Uncontrolled psychiatric problems\n  * Inability to have a caregiver for active oversight during treatment period\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements\n* Evidence of clinical immunocompromise and\u002For HIV positivity and currently receiving antiretroviral therapy\n* Patients requiring chronic supraphysiologic daily doses of steroids (\\> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)\n* Patients receiving any other investigational agent which could be considered a treatment for the neoplasm\n* Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence\n* Diagnosis of autoimmune disease\n\n  * Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded",{"count":113,"type":20},12,[115],"PHASE1","This phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.",[26,56,27,57,118,119,58,120,121,122,59,123,60,124,61,62],"Recurrent Fallopian Tube Carcinosarcoma","Recurrent Female Reproductive System Carcinoma","Recurrent Ovarian Carcinosarcoma","Recurrent Platinum-Resistant Fallopian Tube Carcinoma","Recurrent Platinum-Resistant Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinosarcoma","Refractory Female Reproductive System Carcinoma","2026-03-13",{"date":127,"type":34},"2026-03-16",{"date":129,"type":34},"2024-09-20",{"date":131,"type":20},"2028-09-30",{"name":133,"class":41},"Mayo Clinic",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":141,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":42},"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","ALL",{"count":143,"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.",[26,56,27,147,148,149],"Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","2026-02-05",{"date":152,"type":34},"2026-02-09",{"date":154,"type":34},"2022-09-14",{"date":156,"type":20},"2031-12-31",{"name":133,"class":41},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100582765","phase-3-paclitaxel-lipid-suspension-for-patients-with-platinum-resistant-refractory-ovarian-cancer-100582765","NCT06867562","Paclitaxel Lipid Suspension for Patients with Platinum-Resistant \u002FRefractory Ovarian Cancer","A Phase-3, Randomized, Parallel Group, Open-label, Multicenter, Two-Arm Treatment Study to Evaluate the Efficacy and Safety of Weekly Paclitaxel Lipid Suspension Compared with Weekly Conventional Paclitaxel in the Patients with Platinum-Resistant\u002FRefractory Recurrent High-grade Serous Epithelial Ovarian Cancer Including Fallopian Tube And\u002For Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. The participant is willing to give written signed and dated informed consent to participate in the study.\n2. Female ≥18 years of age fulfilling all other eligibility criteria.\n3. Participants must have histopathologically\u002Fcytologically confirmed diagnosis of high-grade serous epithelial carcinoma of the ovary, fallopian tube cancer or primary peritoneal carcinoma. Non-epithelial or mixed (\\\u003C50% of the primary tumor confirmed to be high-grade serous) epithelial\u002Fnon-epithelial tumors (including malignant mixed Müllerian tumors), ovarian tumors with low malignant potential (borderline tumors), endometrioid, clear cell, mucinous or low-grade serous carcinomas or not otherwise specified (NOS) ovarian tumors are excluded.\n4. Platinum resistant or refractory disease as per standard clinical and Gynecologic Oncology Group definition. Platinum-resistant\u002Frefractory disease is defined as disease progression within 6 months (182 days) following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory), respectively for whom single-agent paclitaxel is considered an acceptable therapeutic option by the investigator.\n5. Participants must have received at least one-prior platinum-based chemotherapy regimen, including cisplatin, carboplatin or other organoplatinum compounds, for treatment of primary or recurrent ovarian, fallopian tube or primary peritoneal cancer.\n6. Have at least one measurable lesion as per the RECIST criteria (version 1.1).\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n8. Left Ventricular Ejection fraction (LVEF) ≥50% as per Echocardiography (ECHO).\n9. Participant has recovered from adverse events (baseline or ≤ CTCAE Grade 1) due to prior anti-cancer therapy(ies) (including surgery, radiotherapy, chemotherapy, targeted therapy, hormonal therapy) unless AE(s) is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator.\n10. Participants with life expectancy of at least 6 months in the Investigator's opinion.\n11. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    * Is not a woman of childbearing potential (WOCBP) OR\n    * Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year) for at least 6 months after the last dose of IMP.\n    * A WOCBP agrees not to donate eggs (ova, oocytes) or freeze them for future use for reproduction during the recommended period of contraception. A WOCBP agrees to seek advice about the donation and cryopreservation of germ cells.\n    * A WOCBP must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test within 24 hours before the first dose of IMP.\n    * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.\n12. Participants with adequate bone marrow, renal and hepatic function\n13. Has had prior PARP inhibitors for participants with documented breast cancer gene (BRCA) mutation (germline and\u002For somatic) or HRD status, unless the participant is not eligible for treatment with a PARP inhibitor due to precautions\u002Fintolerance, or if the treatment is not approved locally or not available due to any reasons.\n14. Has had prior treatment with mirvetuximab soravtansine for participants with documented high folate receptor alpha expression, unless the participant is not eligible for treatment with mirvetuximab soravtansine due to precautions\u002Fintolerance, or if the treatment is not approved or available locally.\n15. Participants must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study.\n\nExclusion Criteria:\n\n1. Have previously received paclitaxel at any time in the platinum-resistant setting. This does not apply to the participants who have received paclitaxel either in a neo\u002Fadjuvant setting in the first line or platinum-sensitive relapse.\n2. Participants who are candidates for debulking surgery, or in whom chemotherapy is planned to shrink the otherwise inoperable tumor and make it operable even if the intent is palliative.\n3. Participants who are planned to receive concurrent PARP inhibitors based on BRCA positivity and HRD status in line with approved indications of respective PARP inhibitors.\n4. Participants who are using known strong CYP3A4 inducers, CYP3A4 inhibitors, CYP2C8 strong inhibitors, and strong inducers.\n5. Participants who are planned for concurrent bevacizumab along with IMP for their disease management during the study. Participants who have received bevacizumab in the past for the management of ovarian cancer are eligible.\n\n   Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently).\n6. Participants with clinically significant current or recent (within the past 6 months before randomization) cardiac conditions as defined below:\n\n   * Unstable angina\n   * Myocardial infarction\n   * Severe uncontrolled ventricular arrhythmias\n   * Clinically significant pericardial disease\n   * Electrocardiographic evidence of acute ischemia\n   * Participants with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable\n   * History of cardiac disease that met the NYHA Classification class 2 or greater\n   * Cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism\n7. Uncontrolled diabetes (defined as HbA1c ≥8% as per ADA) or has an active infection requiring systemic therapy.\n8. History of drug or alcohol abuse according to medical history assessment by the investigator within 1 year before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at Screening.\n9. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks before the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 28 days before trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n10. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days before the first dose of an investigational medicinal product for the current study.\n11. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 as defined by NCI CTCAE v5.0 criteria.\n12. History of clinically significant liver or renal insufficiency; vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that, in the investigator's judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.\n13. Participants who are unwilling or unable to follow protocol requirements.\n14. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.\n15. Prior known hypersensitivity reactions to and\u002For any of their excipients.",{"count":166,"type":20},166,[168],"PHASE3","This is a phase-3, open-label, multicenter, two-arm treatment study to evaluate the efficacy and safety of weekly Paclitaxel Lipid Suspension compared with weekly conventional paclitaxel in participants with platinum-resistant\u002Frefractory recurrent high-grade serous epithelial ovarian cancer.\n\nPaclitaxel Lipid Suspension or conventional paclitaxel will be administered intravenously at a dose level of 80 mg\u002Fm2 on Day 1, Day 8 and Day 15 of each 28 days cycle.\n\nThe primary objective is to establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with conventional paclitaxel for Injection in participants with platinum-resistant\u002Frefractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and\u002For primary peritoneal cancer.\n\nParticipants in both arms will be dosed with the drug until disease progression as assessed by investigator and\u002For unacceptable toxicity.",[27,171,172],"Platinum Resistant High Grade Epithelial Ovarian Cancer","Platinum Resistant High Grade Serous Ovarian Cancer","NOT_YET_RECRUITING","2025-03-07",{"date":176,"type":34},"2025-03-10",{"date":178,"type":20},"2025-04",{"date":180,"type":20},"2026-03",{"name":182,"class":103},"Jina Pharmaceuticals Inc."]