Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Part 1 - Maximum tolerated dose (MTD) of BTP-114 determined during the dose escalation phase of study based on number of patients experiencing a dose-limiting toxicity.
研究概览
简要总结
This is a phase 1, Open-label, multicenter Dose Escalation study of BTP-114, a novel platinum product, in patients with advanced solid tumors and BRCA or other DNA repair mutation. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety, pharmacokinetics and the anti-cancer activity of BTP-114.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BTP-114
Intravenous (IV) treatment n 21-day cycles
干预措施: BTP-114 (Drug)
结局指标
主要结局
Part 1 - Maximum tolerated dose (MTD) of BTP-114 determined during the dose escalation phase of study based on number of patients experiencing a dose-limiting toxicity.
时间窗: From the date of the first dose up to approximately 52 weeks.
Part 1 - Recommended Phase 2 Dose (RP2D) of BTP-114 based on the MTD, review of adverse event data and review of AUC, Tmax and t1/2 obtained from PK data during the dose escalation phase of the study.
时间窗: From the date of the first dose up to approximately 52 weeks.
Part 1 - Number of patients experiencing treatment-related adverse events as assessed by CTCAE v4.3 during the study.
时间窗: From the date of first dose up to approximately 52 weeks.
Part 2 - Proportion of patients with an objective response (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria.
时间窗: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks.
Part 2 - Proportion of patients whose disease is controlled (DCR) using RECIST, Version 1.1 or PCWG2 criteria.
时间窗: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks.
Part 2 - Duration of response (DOR) measured from the date of first CR or PR until the first date of progressive disease or death from any cause.
时间窗: Assessed up to approximately 52 weeks.
Part 2 - Progression-free survival (PFS) measured as the time from the date of initiation of BTP-114 treatment to the documented disease progression (PD) or death from any cause.
时间窗: Assessed up to approximately 52 weeks.
次要结局
未报告次要终点