Actively Recruiting
Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16
90
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether isoquercetin can reduce blood markers that may indicate the risk of blood clots in people with ovarian cancer. This randomized, double-blind, placebo-controlled phase 2 trial compares the effects of isoquercetin to a placebo to better understand its impact on thrombin generation, an important factor in clotting. Participants are randomly assigned to one of three groups: a placebo group, a group taking isoquercetin once daily, or a group taking isoquercetin twice daily. Isoquercetin is taken orally alongside first-line chemotherapy for ovarian cancer, starting with either the first or second cycle of chemotherapy. The study evaluates different dosing regimens over a period of up to 6 weeks. During the study, participants will have blood tests to measure thrombin generation compared to their baseline levels. Researchers will monitor platelet function, organ and marrow health, and overall safety. Participants must use contraception if applicable and will be followed for up to 6 weeks to assess the primary outcome. The total participation duration aligns with chemotherapy cycles and study follow-up.
CONDITIONS
Brief Title
A Study of Isoquercetin in People With Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Minimum age 18 years
- Life expectancy of greater than 6 months.
- ECOG performance status less than 2
- Preserved organ and marrow function including platelet count above 50,000/mcL, prothrombin time and partial thromboplastin time less than 1.5 times institutional upper limit of normal, total bilirubin less than 3 times ULN without liver metastases or less than 5 times ULN with liver metastases, AST and ALT less than 3 times ULN without liver metastases or less than 5 times ULN with liver metastases, and estimated creatinine clearance above 30 ml/min
- Women of child-bearing potential and men must agree to use adequate contraception during study participation
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events with completed anticoagulation)
- Active bleeding or high risk for bleeding such as known acute gastrointestinal ulcer
- History of significant hemorrhage requiring hospitalization or transfusion outside surgical settings within last 24 months
- Familial bleeding disorders
- Known diagnosis of disseminated intravascular coagulation (DIC)
- Currently receiving anticoagulant therapy
- Current daily use of aspirin, clopidogrel, cilostazol, aspirin-dipyridamole within 10 days or regular use of high doses of non-steroidal anti-inflammatory drugs
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Known intolerance to (iso)quercetin, niacin or ascorbic acid including G6PD deficiency
- Known brain metastases
- Pregnant or breastfeeding women due to potential risks with isoquercetin treatment
- Breastfeeding must be discontinued if treated with isoquercetin during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive oral isoquercetin or placebo alongside their first-line chemotherapy to reduce thrombin generation.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 8 locations
1
Beth Israel Deaconess Medical Center (Data Collection Only)
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
J
Jeffrey Zwicker, MD
E
Elizabeth Jewell, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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