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New treatment option for Ovarian Cancer
Official title A Study of Isoquercetin in People With Ovarian Cancer
ClinicalTrials.gov ID: NCT07303894
What this study is testing
What is Isoquercetin?
Isoquercetin is an investigational medicine, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histological- or cytological-confirmed ovarian cancer (epithelial, serous, or clear cell) and be receiving first-line...
- 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:
You likely can't join if
- Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events whereby patients completed...
- 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
See the full eligibility 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.