A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Maximum Observed Plasma Concentration for Repaglinide
研究概览
简要总结
Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients ≥18 years of age.
- •Patients must have a histologic diagnosis of GIST.
- •Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies.
- •Patients must have an Eastern Cooperative Oncology Group performance score of ≤
- •If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
- •Adequate organ and bone marrow function.
排除标准
- •Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
- •Prior treatment with ripretinib.
- •Patients who have had prior repaglinide treatment within 14 days prior to Cycle 1 Day
- •History or presence of clinically relevant cardiovascular abnormalities.
- •Gastrointestinal abnormalities including but not limited to:
- •inability to take oral medication,
- •malabsorption syndromes,
- •requirement for intravenous alimentation.
- •Patients who have type 1 or type 2 diabetes.
研究组 & 干预措施
Repaglinide 0.5 mg + Ripretinib 150 mg QD
A single dose of repaglinide 0.5 mg (1 × 0.5-mg tablet) will be administered orally on Cycle 1 Day 1 and Cycle 1 Day 15. Ripretinib 150 mg QD (3 × 50-mg tablets) will be administered orally from Day 2 through Day 28 for Cycle 1 and will be administered continuously from Cycle 2 until disease progression as assessed by the Investigator, unacceptable toxicity, or withdrawal of consent.
干预措施: Ripretinib (Drug)
Repaglinide 0.5 mg + Ripretinib 150 mg QD
A single dose of repaglinide 0.5 mg (1 × 0.5-mg tablet) will be administered orally on Cycle 1 Day 1 and Cycle 1 Day 15. Ripretinib 150 mg QD (3 × 50-mg tablets) will be administered orally from Day 2 through Day 28 for Cycle 1 and will be administered continuously from Cycle 2 until disease progression as assessed by the Investigator, unacceptable toxicity, or withdrawal of consent.
干预措施: Repaglinide (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration for Repaglinide
时间窗: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Measure the Cmax
Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide
时间窗: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Measure the AUC0-t
AUC from time 0 and extrapolated to infinity (AUC0-∞)
时间窗: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Measure the AUC0-∞
次要结局
- Incidence of Adverse Events(Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.)