EUCTR2015-003047-19-ES进行中（未招募）1 期
An Open label, Multi-Center Phase 1b/2a Trial Investigating Different Doses of Sym004 in Combination with FOLFIRI in Patients with Metastatic Colorectal Cancer Progressing after First-Line Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •?Failed* treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1.
- •Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen.
- •Failed* adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1.
- •*Failure is defined as radiologic progression
- •?Eligible for FOLFIRI
- •?Measurable disease according to RECIST v1.1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •?Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11)
- •?Any antineoplastic agent (standard or investigational) within 4 weeks prior to first administration of trial treatments
- •?Significant gastrointestinal abnormalities, as per defined criteria
- •?Significant cardiovascular disease, as per defined criteria
- •?Abnormal hematologic, renal or hepatic function, as per defined criteria
研究者
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