A Dose-Escalation, Randomized Phase I/II Trial of Zalutumumab - a Human Monoclonal Anti-EGF Receptor Antibody - With or Without Irinotecan Chemotherapy in Cetuximab Refractory Colorectal Cancer Patients Who Have Failed Standard Chemotherapy and Progressed During or Within 3 Months of Stopping Cetuximab-Based Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Genmab
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with 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
- 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
- •Males and Females age ≥ 18 years
- •Confirmed diagnosis of CRC
- •Documented disease progression
- •Failure and/or intolerance to standard chemotherapy
排除标准
- •Prior treatment with anti-EGFR antibodies other than cetuximab
- •Expected survival < 3 months
- •Clinical significant cardiac disease and/or uncontrolled medical conditions
研究组 & 干预措施
Zalutumumab 8 mg/kg
Zalutumumab in combination with Irinotecan
干预措施: Zalutumumab (Drug)
Zalutumumab 16 mg/kg
Zalutumumab in combination with Irinotecan
干预措施: Zalutumumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From first dose up to follow-up (up to approximately 1 year)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
次要结局
- Number of Participants With Best Overall Tumour Response (BOR)(Up to 1 year)