NCT01086267已完成1 期
A Phase 1/2 Study of BMS-908662 (XL281) Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
Bristol-Myers Squibb3 个研究点 分布在 2 个国家目标入组 17 人开始时间: 2010年7月最近更新:
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
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3
研究概览
简要总结
The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab
详细描述
Phase 1: Single Arm Study
Phase 2: Randomized Controlled, Parallel
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.
- •Histologic or cytologic confirmation of the diagnosis.
- •Eastern Cooperative Oncology Group (ECOG) ≤ 1
- •Adequate organ & marrow function.
排除标准
- •Uncontrolled or significant cardiovascular disease.
- •Phase 2: Prior therapy with a RAF inhibitor.
研究组 & 干预措施
BMS-908662 (A1)
Experimental
Phase 1
干预措施: BMS-908662 (Drug)
Cetuximab (A1)
Experimental
Phase 1
干预措施: Cetuximab (Drug)
BMS-908662 (B1)
Experimental
Phase 2
干预措施: BMS-908662 (Drug)
BMS-908662 + Cetuximab (B2)
Experimental
Phase 2
干预措施: BMS-908662 (Drug)
BMS-908662 + Cetuximab (B2)
Experimental
Phase 2
干预措施: Cetuximab (Drug)
结局指标
主要结局
Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3
时间窗: Assessments every 1-2 weeks while receiving study drug
次要结局
- Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].(PK measured during first 4 weeks on study)
- Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)].(PK measured during first 4 weeks on study)
- Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity(PD assessed during the first 4 weeks on study)
- Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].(PK measured during first 4 weeks on study)
- Efficacy as determined by estimates of objective response rates and response duration(Efficacy measured at least every 8 weeks while receiving study drug)
- Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].(PK measured during first 4 weeks on study)
- Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].(PK measured during first 4 weeks on study)
研究者
研究点 (3)
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