A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245408 Polymorph E Administered Once Daily to Subjects With Solid Tumors or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
Primary Objective:
- To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.
详细描述
Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment visit: no later than 7 days after the last study drug administration Subjects not eligible for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration Subjects eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll in the treatment-extension study TED12414.
Total duration of study participation for each patient: 58 to 118 days.
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
SAR245408 polymorph E tablets
Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles
干预措施: SAR245408 (Drug)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: Up to Day 28
次要结局
- Maximum SAR245408 plasma concentration(Days 1, 2, 8, 15, 29 and 30)
- Area under the SAR245408 plasma concentration versus time curve(Days 1, 2, 8, 15, 29 and 30)
- Number of patients with treatment-emergent adverse events(From first dose of SAR245408 up to 30 days after the last dose)