Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
- Conditions
- ntreated Metastatic Colorectal CancerMedDRA version: 19.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002866-65-AT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
• = 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method