Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:20 AM
Study NCT ID:
NCT07303894
Status:
RECRUITING
Last Update Posted:
2026-01-29
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Isoquercetin in People With Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C016527', 'term': 'isoquercitrin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline', 'timeFrame': 'up to 6 weeks from baseline', 'description': 'The primary endpoint is the maximal inhibition of PDI-sensitive, platelet-dependent thrombin generation measured at either 3 or 6 weeks (relative to baseline).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovarian Cancer', 'Epithelial Ovarian Cancer', 'Serous Ovarian Tumor', 'Isoquercetin', 'Memorial Sloan Kettering Cancer Center', '25-060'], 'conditions': ['Ovarian Cancer', 'Epithelial Ovarian Cancer', 'Serous Ovarian Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\<2\n* Participants must have preserved organ and marrow function as defined below:\n\n * Platelet count \\> 50,000/mcL\n * Prothrombin time (PT) and partial thromboplastin time (PTT) \\< 1.5 x institutional upper limit of normal (ULN)\n * Total bilirubin \\< 3 x ULN without liver metastases and \\<5 x ULN in presence of liver metastases.\n * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\< 3 X ULN without liver metastases and \\<5 x ULN in the presence of liver metastases.\n * Estimated creatinine clearance (CrCl \\>30 ml/min)\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/social 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.'}, 'identificationModule': {'nctId': 'NCT07303894', 'briefTitle': 'A Study of Isoquercetin in People With Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer', 'orgStudyIdInfo': {'id': '25-060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort A: Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B: Isoquercetin daily', 'interventionNames': ['Drug: Isoquercetin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C: Isoquercetin twice daily', 'interventionNames': ['Drug: Isoquercetin']}], 'interventions': [{'name': 'Isoquercetin', 'type': 'DRUG', 'description': 'Cohort B and Cohort C will take isoquercetin', 'armGroupLabels': ['Cohort B: Isoquercetin daily', 'Cohort C: Isoquercetin twice daily']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Cohort A: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Flaumenhaft, MD, PhD', 'role': 'CONTACT', 'phone': '617-735-4005'}], 'facility': 'Beth Israel Deaconess Medical Center (Data Collection Only)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey A Zwicker, MD', 'role': 'CONTACT', 'phone': '646-608-3723'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (All Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Zwicker, MD', 'role': 'CONTACT', 'phone': '646-608-3723'}], 'facility': 'Memorial Sloan Kettering Monmouth (All Protocol Activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Zwicker, MD', 'role': 'CONTACT', 'phone': '646-608-3723'}], 'facility': 'Memorial Sloan Kettering Bergen (All Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Zwicker, MD', 'role': 'CONTACT', 'phone': '646-608-3723'}], 'facility': 'Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Zwicker, MD', 'role': 'CONTACT', 'phone': '646-608-3723'}], 'facility': 'Memorial Sloan Kettering Westchester (All Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Zwicker, MD', 'role': 'CONTACT', 'phone': '646-608-3723'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Zwicker, MD', 'role': 'CONTACT', 'phone': '646-608-3723'}], 'facility': 'Memorial Sloan Kettering Nassau (All protocol activities)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'Jeffrey Zwicker, MD', 'role': 'CONTACT', 'email': 'zwickerj@mskcc.org', 'phone': '646-608-3723'}, {'name': 'Elizabeth Jewell, MD', 'role': 'CONTACT', 'email': 'jewelle@mskcc.org', 'phone': '212-639-3366'}], 'overallOfficials': [{'name': 'Jeffrey Zwicker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}