NCT01596270已完成1 期
A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma
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
- 49
- 试验地点
- 3
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
Primary Objective:
- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.
Secondary Objectives:
- To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
- To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma.
- To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
- To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire.
- To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.
详细描述
The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
Once daily dosing
Experimental
escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose
干预措施: SAR245409 (Drug)
Twice daily dosing
Experimental
escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose
干预措施: SAR245409 (Drug)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: Up to Day 28
次要结局
- Maximum SAR245409 plasma concentration(Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1)
- Number of patients with treatment-emergent adverse events(From first dose of SAR245409 until 30 days after the last dose)
- Area under the SAR245409 plasma concentration versus time curve(Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1)
- Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing(Days 1, 2, 3, and 4 of the food interaction period)
- Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing(Days 1, 2, 3, and 4 of the food interaction period)
研究者
研究点 (3)
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