EUCTR2014-002866-65-ES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 chemotherapy must have ended > 12 months prior to colorectal cancer recurrence;
- •? 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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