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Recruiting NCT07303894

A Study of Isoquercetin in People With Ovarian Cancer

Phase II Interventional Ovarian Cancer Epithelial Ovarian Cancer Serous Ovarian Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isoquercetin, Placebo.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Epithelial Ovarian Cancer, Serous Ovarian Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer

Overview

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.

Interventions

  • Drug Isoquercetin
    Cohort B and Cohort C will take isoquercetin
  • Other Placebo
    Placebo

Primary outcome measures

  • Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline [Time frame: up to 6 weeks from baseline]

Eligibility criteria

Inclusion criteria

  • 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 <2
  • Participants must have preserved organ and marrow function as defined below:
  • Platelet count > 50,000/mcL
  • Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (ULN)
  • Total bilirubin < 3 x ULN without liver metastases and <5 x ULN in presence of liver metastases.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 X ULN without liver metastases and <5 x ULN in the presence of liver metastases.
  • Estimated creatinine clearance (CrCl >30 ml/min)
  • 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.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events whereby patients completed anticoagulation)
  • Active bleeding or high risk for bleeding (e.g., known acute gastrointestinal ulcer)
  • History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
  • Familial bleeding diathesis
  • Known diagnosis of disseminated intravascular coagulation (DIC)
  • Currently receiving anticoagulant therapy
  • 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)
  • 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
  • Known intolerance of (iso)quercetin, niacin or ascorbic acid (including known G6PD deficiency).
  • Participants with known brain metastases
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Beth Israel Deaconess Medical Center (Data Collection Only) — Boston
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
  • Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre

Identifiers

NCT: NCT07303894 · 25-060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗