A Phase 1 Study of Combination Therapy With SAR405838 and Pimasertib in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities
研究概览
简要总结
Primary Objectives:
To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors.
To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.
Secondary Objectives:
To characterize the pharmacokinetic profile of SAR405838 and pimasertib.
To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.
To characterize genetic status in tumor tissue and circulating tumor DNA.
详细描述
The duration of the study for an individual patient will include a period to assess eligibility of up to 4 weeks, a treatment period of at least 6 weeks of study treatment, and an end-of-study visit at least 30 days (or until the patient receives another anti-cancer therapy, whichever is shorter) following the last administration of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Arm 1
SAR405838 and pimasertib in escalating doses
干预措施: SAR405838 (Drug)
Arm 1
SAR405838 and pimasertib in escalating doses
干预措施: Pimasertib (Drug)
结局指标
主要结局
SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities
时间窗: 6 weeks for each patient at each dose level
Changes of tumor dimension by imaging
时间窗: At least 3 months for each patient
次要结局
- Pharmacokinetic parameters for both SAR405838 (pimasertib): area under the curve (AUC), etc.(3 months for each patient)
- Biomarker changes in response to SAR405838 (pimasertib) treatment(3 months for each patient)
- Genetic status in tumor tissue(Baseline)
- Change of the genetic status of circulating tumor DNA(Baseline and until disease progression)
- Overall safety profile of SAR405838 (pimasertib), number of participants with adverse events(Throughout the study)
- Pharmacokinetic parameters for both SAR405838 (pimasertib): the maximum concentration in blood (Cmax)(3 months for each patient)
- Pharmacokinetic parameters for both SAR405838 (pimasertib): time to the maximum concentration (Tmax)(3 months for each patient)