A Phase 1b Trial of the Cyclin-dependent Kinase Inhibitor Dinaciclib in Combination With Pembrolizumab in Patients With Advanced Breast Cancer and Assessment of MYC Oncogene Overexpression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Proportion of participants with reported dose-limiting toxicities (DLTs)
研究概览
简要总结
The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients with metastatic or locally advanced and unresectable triple negative breast cancer, to evaluate the efficacy of combined dinaciclib and pembrolizumab.
详细描述
PRIMARY OBJECTIVE:
I. Define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of dinaciclib
SECONDARY OBJECTIVE:
I. Evaluation of the preliminary efficacy of this combination using RECIST 1.1 and irRECIST.
EXPLORATORY OBJECTIVE:
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 85 Years（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
Treatment (Dinaciclib, Pembrolizumab)
Pembrolizumab will be administered on Day 1, every 3 weeks at a fixed dose of 200 mg IV. Dinaciclib will be administered D1 and D8 of a 21 day cycle by 2-hour intravenous infusion starting at Dose Level (DL) 1 of 12 mg/m^2. Further dose escalation cohorts are defined as follows: DL 2: 18 mg/m^2, DL 3: 25 mg/m^2, DL 4: 33 mg/m^2, and DL 5: 50 mg/m^2
干预措施: Dinaciclib (Drug)
Treatment (Dinaciclib, Pembrolizumab)
Pembrolizumab will be administered on Day 1, every 3 weeks at a fixed dose of 200 mg IV. Dinaciclib will be administered D1 and D8 of a 21 day cycle by 2-hour intravenous infusion starting at Dose Level (DL) 1 of 12 mg/m^2. Further dose escalation cohorts are defined as follows: DL 2: 18 mg/m^2, DL 3: 25 mg/m^2, DL 4: 33 mg/m^2, and DL 5: 50 mg/m^2
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Proportion of participants with reported dose-limiting toxicities (DLTs)
时间窗: Up to 1 cycle (1 cycle is equal to 21 days)
Dose-limiting hematologic and non-hematologic toxicities classified using the CTCAE, will be based on events occurring during the first cycle of study drug administration. To be considered a dose-limiting toxicity, an adverse experience must be related to one or both of the study drugs, and must not be related to disease progression or intercurrent illnesses. Participants must receive Day 1 and Day 8 treatments of dinaciclib during the first cycle in order to be evaluable for DLTs (unless missed doses are due to toxicity).
Maximum tolerated dose (MTD)
时间窗: Up to 1 cycle (1 cycle is equal to 21 days)
The MTD is determined by the number of dose-limiting toxicities reported by participants in the first cycle of treatment.
次要结局
- Overall Response Rate(Up to 3 years)
研究者
Jo Chien
UCSF Assistant Clinical Professor
University of California, San Francisco