[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-primary-peritoneal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-primary-peritoneal-carcinoma":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100366775","phase-2-onc201-plus-weekly-paclitaxel-in-patients-with-platinum-refractory-or-resistant-ovarian-cancer-100366775",false,"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.","FEMALE","18 Years",{"count":19,"type":20},62,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30,31,32,33,34,35],"Malignant Ovarian Epithelial Tumor","Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Ovarian Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Refractory Fallopian Tube Carcinoma","Refractory Ovarian Carcinoma","Refractory Primary Peritoneal Carcinoma","RECRUITING","2026-06-15",{"date":39,"type":40},"2026-06-17","ACTUAL",{"date":42,"type":40},"2020-01-21",{"date":44,"type":20},"2027-05-28",{"name":46,"class":47},"Ira Winer","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"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":56,"type":20},12,[58],"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.",[27,28,29,30,61,62,31,63,64,65,32,66,33,67,34,35],"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":70,"type":40},"2026-03-16",{"date":72,"type":40},"2024-09-20",{"date":74,"type":20},"2028-09-30",{"name":76,"class":47},"Mayo Clinic",1]