A Study of Isoquercetin in People With Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Isoquercetin
DrugCohort B and Cohort C will take isoquercetin
Placebo
Other interventionPlacebo
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Cohort A: PlaceboPlacebo comparator 1 intervention
Group B: Cohort B: Isoquercetin dailyExperimental treatment 1 intervention
Group C: Cohort C: Isoquercetin twice dailyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline
The primary endpoint is the maximal inhibition of PDI-sensitive, platelet-dependent thrombin generation measured at either 3 or 6 weeks (relative to baseline).
Time frame
up to 6 weeks from baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov