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临床试验/NCT00813605
NCT00813605已完成2 期

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

NantCell, Inc.68 个研究点 分布在 8 个国家目标入组 155 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
155
试验地点
68
主要终点
Progression Free Survival

研究概览

简要总结

This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

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
Double (Participant, 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

入选标准

  • Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  • Mutant-type KRAS tumor at screening
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
  • Adequate hematology, renal, hepatic, and coagulation function

排除标准

  • History or known presence of central nervous system metastases
  • History of other malignancy
  • Prior irinotecan-based chemotherapy for advanced/metastatic disease
  • Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
  • Uncontrolled cardiovascular disease

结局指标

主要结局

Progression Free Survival

时间窗: Length of Study

次要结局

  • Significant laboratory abnormalities(Length of Study)
  • Incidence of antibody formation(Length of Study)
  • Overall Survival, Objective Response, Duration of Response, Time to Response(Length of Study)
  • Incidence of adverse events(Length of Study)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (68)

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