A Randomized Phase 2 Clinical Trial of IMC-A12, as a Single Agent or in Combination With Cetuximab, in Patients With Metastatic Colorectal Cancer With Disease Progression on Prior Anti-EGFR Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response [PR, Objective Response Rate (ORR)]
研究概览
简要总结
Participants with metastatic Colorectal Cancer (mCRC) who have progressed on a prior Anti-epidermal growth factor receptor (EGFR) regimen randomized to receive IMC-A12 monotherapy or combination therapy with cetuximab to assess response, survival, durations of response, safety and tolerability as well as pharmacodynamics of IMC-A12 and cetuximab
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IMC-A12 + cetuximab
Administered every 2 weeks
干预措施: IMC-A12 (Biological)
IMC-A12
Administered every 2 weeks
干预措施: IMC-A12 (Biological)
IMC-A12 + cetuximab [Kirsten rat sarcoma (K-ras) wild-type]
Participants who have experienced confirmed partial response (PR) or stable disease (SD) ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression are enrolled in this arm.
干预措施: IMC-A12 (Biological)
IMC-A12 + cetuximab
Administered every 2 weeks
干预措施: cetuximab (Biological)
IMC-A12 + cetuximab [Kirsten rat sarcoma (K-ras) wild-type]
Participants who have experienced confirmed partial response (PR) or stable disease (SD) ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression are enrolled in this arm.
干预措施: cetuximab (Biological)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response [PR, Objective Response Rate (ORR)]
时间窗: Start of randomization/treatment to date of objective progressive disease (PD) up to 28.3 weeks
ORR is the percentage of participants with a confirmed CR or PR, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from start of the treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
次要结局
- Progression-Free Survival (PFS)(Randomization/treatment to measured PD up to 28.3 weeks)
- Duration of Stable Disease (SD)(Time from randomization/treatment to first date of PD up to 28.3 weeks)
- Number of Participants Reporting Treatment-Emergent Severe Adverse Events(Randomization/treatment up to 26.9 months)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR, Response Rate) in Participants With Kirsten Rat Sarcoma (K-ras) Mutations(Treatment up to 26.9 months)
- Overall Survival (OS)(Randomization/treatment to date of death from any cause up to 26.9 months)
- Expression of IGF Binding Proteins (IGFBP2, IGFBP3)(Randomization/treatment up to 26.9 months)
- Duration of Overall Response(Time of response to time of measured PD or death up to 161 days)
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)(Randomization/treatment up to 26.9 months)
- Maximum Concentration (Cmax)(Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6))
- Minimum Concentration (Cmin)(Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6))
- Area Under Serum Concentration (AUC)(Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6))
- Expression of Type I Insulin-Like Growth Factor Receptors (IGF-IR)(Randomization/treatment up to 26.9 months)