EUCTR2014-002866-65-BEActive, not recruitingPhase 1
Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI ± Bevacizumab Versus Placebo Plus FOLFIRI ± Bevacizumab inPreviously Untreated Metastatic Colorectal Cancer
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •= 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
Exclusion Criteria
- •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.
- •Subject has received an investigational drug within the 28 days prior to Screening.
- •Any subjects will be excluded if prohibited from participation according to local laws or regulations.
- •For those receiving bevacizumab, standard medical exclusionary conditions apply.
Investigators
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