NCT01392924已完成1 期
An Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of SAR245408 Administered Orally Daily in Patients With Solid Tumors
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
- 10
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity in cycle 1
研究概览
简要总结
Primary Objective:
- To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors.
Secondary Objectives:
- To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408 in CDD treatment schedule in patients with solid tumors.
- To gather preliminary efficacy data after repeated administration of SAR245408 in patients with solid tumors.
详细描述
The duration of the study for 1 patient will include a period for screening up to 28 days, the study treatment period, followed by a 28-day follow-up after the last study drug administration.
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
- 20 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
Experimental
single cohort: SAR245408 administered once daily
干预措施: SAR245408 (Drug)
结局指标
主要结局
Dose limiting toxicity in cycle 1
时间窗: 4 weeks
次要结局
- Number of treatment emergent adverse events(28 days after the last dosing)
- Number of serious adverse events(28 days after the last dosing)
- Number of abnormality of laboratory test as graded by National Cancer Institute-Common Toxicity Criteria(28 days after the last dosing)
- Pharmacokinetics (Cmax) of SAR245408(an expected average of 3 months)
- Pharmacokinetics (tmax) of SAR245408(an expected average of 3 months)
- Pharmacokinetics (AUC) of SAR245408(an expected average of 3 months)
- Pharmacokinetics (accumulation ratio) of SAR245408(an expected average of 3 months)
- Pharmacokinetics (Ctrough) of SAR245408(an expected average of 3 months)
- Objective tumor response as defined by RECIST (response evaluation criteria in solid tumors)(At 8 weeks and every 2 months thereafter)
研究者
研究点 (2)
Loading locations...
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