NCT00752570已完成2 期
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 144
- 主要终点
- To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo.
研究概览
简要总结
This clinical trial will compare the efficacy and safety of the combination of AMG 386 and FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
- •One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
- •At least one uni dimensionally measurable lesion per modified RECIST criteria. All sites of disease must be evaluated <= 28 days before randomization
- •Radiographically documented disease progression per modified RECIST criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
- •ECOG performance status of 0 or 1
- •Man or woman >= 18 years of age
- •Adequate end organ assessments by laboratory studies (hematological and chemistries)
- •Life expectancy >= 3 months
排除标准
- •Exclude subjects with a history of prior malignancy, except:
- •Malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
- •Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Prior irinotecan therapy
- •Systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization
- •Experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization
- •Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
- •Known allergy or hypersensitivity to irinotecan, 5 FU (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= CTC grade 2 [CTCAE version 3.0])
研究组 & 干预措施
2
Placebo Comparator
AMG 386 placebo QW, FOLFIRI Q2W
干预措施: AMG 386 Placebo (Drug)
2
Placebo Comparator
AMG 386 placebo QW, FOLFIRI Q2W
干预措施: FOLFIRI (Drug)
1
Active Comparator
Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W
干预措施: AMG 386 (Drug)
1
Active Comparator
Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W
干预措施: FOLFIRI (Drug)
结局指标
主要结局
To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo.
时间窗: The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).
次要结局
- To evaluate progression free survival and measures of efficacy by KRAS status(Treatment phase)
- To evaluate other measures of efficacy or clinical response including objective response rate (ORR), duration of response (DOR), overall survival (OS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo(Treatment phase or until disease progression)
- To evaluate patient reported outcomes (PROs), relative dose intensity, incidence of anti AMG 386 antibody formation, pharmacokinetics of AMG 386 (Cmax and AUC) and safety (incidence of AEs and significant laboratory changes)(Throughout study)
研究者
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