NCT00547261终止1 期
Phase I Dose Escalation and Pharmacokinetic Study of SSR97225 Administered as a 1 Hour IV Infusion D1 Every 3 Weeks (Arm A) or Administered as a 1hour IV Infusion D1, D8, D15 Every 3 Weeks (Arm B) in Patients With Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximal tolerated dose (MTD) and dose limiting toxicity (DLT)
研究概览
简要总结
The purpose of this study is to determine the maximally tolerated dose and the dose limiting toxicity of this antimitotic, tubulin binding investigational drug for those patients who have failed standard anticancer treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of metastatic or locally advanced non-hematological cancer
- •Patients with solid tumors refractory to therapy or for whom no therapy exists
排除标准
- •Five or more prior chemotherapy lines for metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) performance status >2
- •Patients having discontinued previous specific anti-cancer treatment
- •Patients who have not recovered from all toxic effects from previous specific anti-cancer treatment (excluding alopecia)
- •Patients with abnormal biological/hematological parameters, cardiac abnormalities or serious infection/intercurrent illness likely to jeopardize the patient's safety or the course of the protocol treatment
- •No adequate birth control methods
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Arm A
Experimental
1 hour IV infusion D1
干预措施: SSR97225 (Drug)
Arm B
Experimental
1 hour IV infusion D1, D8, D15
干预措施: SSR97225 (Drug)
结局指标
主要结局
Maximal tolerated dose (MTD) and dose limiting toxicity (DLT)
时间窗: Study period
次要结局
- Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity(Study period)
研究者
研究点 (1)
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