NCT07303894招募中2 期
Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort A: Placebo
Placebo Comparator
干预措施: Placebo (Other)
Cohort B: Isoquercetin daily
Experimental
干预措施: Isoquercetin (Drug)
Cohort C: Isoquercetin twice daily
Experimental
干预措施: Isoquercetin (Drug)
结局指标
主要结局
Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline
时间窗: up to 6 weeks from 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).
次要结局
未报告次要终点
研究者
研究点 (8)
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