NL-OMON29791已完成3 期
A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer - Eff P'mab+chemo versus chemo in treated metastatic colorectal cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with adenocarcinoma of the colon or rectum, who are presenting with metastatic disease.
- •Received one and only one prior chemotherapy regimen consisting of fluoropyrimidine-based chemotherapy.
- •At least one uni-dimensionallly measurable lesion of at least 20 mm per modified RECIST criteria.
排除标准
- •History or known presence of central nervous system metastases
- •History of another primary cancer (exceptions see page 32)
- •Prior irinotecan therapy
- •Prior anti-EGFr antibody therapy or treatment with small molecule EGFr inhibitors.
- •Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies < or = 30 days before randomization
- •Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for randomization.
- •Radiotherapy < or = 14 days prior to randomization
- •Active infection requiring systemic treatment or any uncontrolled infection < or = 14 days prior to randomization
- •Any investigational agent or therapy < or = 30 days before randomization
研究者
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