NCT01636479已完成1 期
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 77
- 试验地点
- 7
- 主要终点
- SAR405838 Maximum tolerated dose (MTD)
研究概览
简要总结
Primary Objectives:
- To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).
- To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion.
Secondary Objectives:
- Pharmacokinetic (PK) profile of SAR405838.
- Biomarkers in association with SAR405838.
- Anti-tumor activity in response to SAR405838.
- Food effect on SAR405838 PK.
- Compliance with SAR405838 treatment.
- Cytochrome P450 3A4/5 (CYP3A4/5) activity.
详细描述
Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.
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
SAR405838
Experimental
SAR405838 in escalating doses
干预措施: SAR405838 (Drug)
结局指标
主要结局
SAR405838 Maximum tolerated dose (MTD)
时间窗: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule
In MTD cohort, clinical benefit
时间窗: Until disease progression
次要结局
- PK parameters (Cmax, Tmax, AUC)(Baseline to end of study)
- Biomarkers(Baseline to end of study)
- Clinical response(Baseline to end of study)
- Adverse events (eg, number of patients experiencing AEs)(Baseline to end of study)
- Drug administration compliance(Baseline to end of study)
研究者
研究点 (7)
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