EUCTR2014-002866-65-DE进行中（未招募）1 期
Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI ± Bevacizumab Versus Placebo Plus FOLFIRI ± Bevacizumab inPreviously Untreated Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •= 18 years of age;
- •Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum;
- •At least 1 unresectable lesion on a CT scan that is measurable as defined by RECIST, Version 1.1;
- •ECOG performance score of 0 or 1;
- •Adequate hematologic, renal and hepatic function.
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •Prior anti-cancer treatment for metastatic colorectal cancer;
- •Prior exposure to PARP inhibitors;
- •The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to C1D-2;
- •Any Clinically significant and uncontrolled major medical condition;
- •Subject is pregnant or lactating;
- •Any medical condition, which in the opinion of the study Investigator, places the subject at an unacceptably high risk for toxicities.
- •For those receiving bevacizumab, standard medical exclusionary conditions apply.
研究者
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