A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 169
- 主要终点
- Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
研究概览
简要总结
This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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
- •Adult patients, >/= 18 years of age
- •Carcinoma of the colon and/or rectum
- •Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease
- •ECOG performance status 0-1
- •Adequate hematological, renal and liver function
排除标准
- •Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR)
- •Prior treatment with irinotecan
- •Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)
- •CNS metastasis
- •History of or active autoimmune disorders/conditions
研究组 & 干预措施
KRAS WT A
干预措施: FOLFIRI (Drug)
KRAS WT A
干预措施: RO5083945 (Drug)
KRAS WT B
干预措施: FOLFIRI (Drug)
KRAS WT B
干预措施: cetuximab (Drug)
KRAS mutant A
干预措施: FOLFIRI (Drug)
KRAS mutant A
干预措施: RO5083945 (Drug)
KRAS mutant B
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
时间窗: approximately 18 months
次要结局
- Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa(approximately 18 months)
- Overall survival(approximately 18 months)
- Safety: Incidence of adverse events(approximately 18 months)
- Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria(approximately 18 months)
- Duration of response: time from complete or partial response to disease progression or death(approximately 18 months)
- Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria(approximately 18 months)