Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 65
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
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
- •Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- •Primary tumor has been resected > 3 months prior to randomization.
- •At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0 or
- •Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.
- •Adequate hematologic, renal and hepatic function.
排除标准
- •Any prior therapy with irinotecan
- •Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
- •Clinically significant conditions that increase the risk for antiangiogenic therapy.
- •History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
研究组 & 干预措施
ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Leucovorin (Drug)
ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Fluorouracil - bolus (Drug)
ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Fluorouracil - infusion (Drug)
ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: ABT-165 (Drug)
ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Irinotecan (Drug)
Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Leucovorin (Drug)
Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Fluorouracil - bolus (Drug)
Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Bevacizumab (Drug)
Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Fluorouracil - infusion (Drug)
Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
干预措施: Irinotecan (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively
PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
次要结局
- Objective Response Rate (ORR)(From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively)
- Overall Survival (OS)(Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively)