[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"serous-ovarian-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:serous-ovarian-tumor":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100529944","phase-2-niraparib-rechallenge-after-surgery-in-ovarian-cancer-patients-with-oligometastatic-progression-100529944",false,"NCT06180356","Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression","Phase II Study to Assess the Efficacy of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression (The ANALLISA Study)","ANALLISA","Inclusion Criteria:\n\n1. Written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female patients ≥ 18 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Patients must have a life expectancy ≥16 weeks.\n5. Histologically confirmed high grade serous or endometrioid OC who have an OMP during or after the first maintenance therapy with any PARPi.\n6. Oligometastatic progression defined as 1-5 lesions (according to European Society for Radiotherapy and Oncology \\[ESTRO\\] and American Society for Radiation Oncology \\[ASTRO\\] consensus).\n\n   Note: Metastatic lymph nodes located within the same anatomical lymph-node chain or station, as confirmed on surgical specimen, shall be counted collectively as one single metastatic lesion.\n7. Patients must have undergone secondary cytoreductive surgery with centrally confirmed no evidence of macroscopic residual tumor after surgery (complete resection).\n8. Patients with asymptomatic and treated brain metastases are allowed if:\n\n1\\. Neurosurgical resection ≥ 28 days prior to initiation of study treatment. 2. Not requiring radiotherapy. 3. Not receiving steroid therapy or anticonvulsant for at least 7 days before the first dose of study treatment.\n\n9\\. Documented breast cancer gene 1\u002F2 (BRCA1\u002F2) status and\u002For homologous recombination (HR) status.\n\nNote I: Patients with germline or somatic mutations in the BRCA1 or BRCA2 genes will be considered with the HR status known and classified as with homologous recombination deficiency (HRD).\n\nNote II: HR test must be performed before C1D1.\n\n10\\. Patients who have received prior PARPi monotherapy or PARPi together with bevacizumab as maintenance treatment.\n\n11\\. Patients should have had benefit of prior PARPi defined by treatment for ≥12 months from initiation of PARPi maintenance until the date of OMP or have experienced tumor progression after treatment completion. Tumor progression must have been confirmed by computed tomography (CT) and\u002For PET-CT scan.\n\n12\\. If prior treatment was niraparib, no significant toxicity that led to treatment discontinuation.\n\n13\\. Willingness to provide formalin fixed, paraffin embedded (FFPE) tumor tissue from primary, if available, and secondary surgeries and blood samples at the time of the inclusion, every 12 weeks, and at the end of treatment (EoT).\n\n14\\. Able to take oral medications. 15. Patients must start treatment 3 to 8 weeks from surgery, once recovered from surgery.\n\n16\\. Women of childbearing potential who engage in heterosexual intercourse must agree to use institution specified method(s) of contraception and must refrain from donating eggs in the time period specified in the study protocol. Women of childbearing potential must have a negative serum or a highly sensitive urine pregnancy test within 72 hours before study treatment initiation.\n\n17\\. Patient has adequate bone marrow, liver, and renal function:\n\n* Hematological: White blood cell (WBC) count \\> 3.0 x 109\u002FL, absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL, platelet count ≥ 100.0 x109\u002FL, and hemoglobin ≥ 9.0 g\u002FdL (≥ 5.6 mmol\u002FL).\n* Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN. 11).\n* Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n\n  18\\. Patients must be accessible for treatment follow-up.\n\nExclusion Criteria:\n\n1. Patients with symptomatic or systemic progressive disease not fulfilling OMP disease criteria.\n2. Patients with residual disease after secondary cytoreductive surgery.\n3. Patients with persistent toxicities (\\> Common Terminology Criteria for Adverse Events (CTCAE) grade 2) caused by previous cancer therapy.\n4. Patients unable to swallow oral medication or with any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of niraparib, or put the study outcomes at undue risk.\n5. Patients with clinically significant cardiovascular disease such as uncontrolled hypertension, uncontrolled or symptomatic arrythmias, congestive heart failure (CHF), or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification.\n6. Patients treated with previous PARPi therapy who have any known, persistent (\\>4 weeks), ≥Grade 3 anemia, neutrophil count decrease or platelet count decrease.\n7. Patients with known history of human immunodeficiency virus (HIV), or active hepatitis C Virus (HCV), or active hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.\n8. Patients with known hypersensitivity or allergy to prior niraparib treatment or any of the excipients of the product.\n9. Patients who have received a transfusion of platelets or red blood cells, colony-stimulating factors or have any other laboratory abnormality within 2 weeks prior niraparib treatment that might confound or interfere with the study result.\n10. Participation in another clinical trial, interventional or observational, until the Study's safety visit.\n\n    Note: participation in retrospective studies or data analysis is allowed.\n11. Patients who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study treatment.\n12. Patients with myelodysplastic syndrome (MSD)\u002FAcute myeloid leukemia (AML), with history of MSD\u002FAML or with features suggestive of MDS\u002FAML.\n13. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n14. Other malignancy unless curatively treated with no evidence of disease ≥ 5 years prior to study enrollment. Note: Patients with adequately non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) and stage 1 low grade endometrial carcinoma are not excluded.\n15. Vaccination with any live virus vaccine within 28 days prior study treatment initiation.","FEMALE","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with oligometastatic progression (OMP) after first maintenance therapy with any PARP inhibitor. A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg, according to body weight or platelet count. Patients will start treatment within 8 weeks after surgery and will receive it until progressive disease or treatment discontinuation. The main purpose of the study is to evaluate progression-free survival (PFS) of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery.",[27,28,29],"Ovarian Cancer","Oligometastatic Disease","Serous Ovarian Tumor","RECRUITING","2026-04-17",{"date":33,"type":34},"2026-04-22","ACTUAL",{"date":36,"type":34},"2024-12-03",{"date":38,"type":21},"2028-01",{"name":40,"class":41},"MedSIR","OTHER",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100616306","phase-2-a-study-of-isoquercetin-in-people-with-ovarian-cancer-100616306","NCT07303894","A Study of Isoquercetin in People With Ovarian Cancer","Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer","Inclusion Criteria:\n\n* Participants must have histological- or cytological-confirmed ovarian cancer (epithelial, serous, or clear cell) and be receiving first-line chemotherapy (day 1 of isoquercetin should align with day 1 of cycle 1 or 2 of chemotherapy) for neoadjuvant, adjuvant, or advanced settings.\n* Minimum age 18 years\n* Life expectancy of greater than 6 months.\n* ECOG performance status \\\u003C2\n* Participants must have preserved organ and marrow function as defined below:\n\n  * Platelet count \\> 50,000\u002FmcL\n  * Prothrombin time (PT) and partial thromboplastin time (PTT) \\\u003C 1.5 x institutional upper limit of normal (ULN)\n  * Total bilirubin \\\u003C 3 x ULN without liver metastases and \\\u003C5 x ULN in presence of liver metastases.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 X ULN without liver metastases and \\\u003C5 x ULN in the presence of liver metastases.\n  * Estimated creatinine clearance (CrCl \\>30 ml\u002Fmin)\n* The effects of isoquercetin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events whereby patients completed anticoagulation)\n* Active bleeding or high risk for bleeding (e.g., known acute gastrointestinal ulcer)\n* History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months\n* Familial bleeding diathesis\n* Known diagnosis of disseminated intravascular coagulation (DIC)\n* Currently receiving anticoagulant therapy\n* Current daily use of aspirin, clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g ibuprofen \\> 800 mg daily or equivalent)\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* Known intolerance of (iso)quercetin, niacin or ascorbic acid (including known G6PD deficiency).\n* Participants with known brain metastases\n* Pregnant women are excluded from this study because isoquercetin is a PDI inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with isoquercetin, breastfeeding should be discontinued if the mother is treated with isoquercetin.","ALL",{"count":52,"type":21},90,[24],"The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo.",[27,56,29],"Epithelial Ovarian Cancer",[27,56,29,58,59,60],"Isoquercetin","Memorial Sloan Kettering Cancer Center","25-060","2026-04-15",{"date":63,"type":34},"2026-04-16",{"date":65,"type":34},"2026-01-22",{"date":67,"type":21},"2032-01",{"name":59,"class":41},8]