Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer

Phase 1

• Conditions: ntreated Metastatic Colorectal Cancer; MedDRA version: 18.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002866-65-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-05
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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.
• 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
Main Objective: The primary objectives of the study is to assess whether the addition of oral veliparib to FOLFIRI will improve progression-free survival (PFS) in subjects with metastatic colorectal cancer (mCRC). ;Secondary Objective: The secondary objectives of the study is to assess overall survival (OS), objective response rate (ORR), safety, and tolerability. ;Primary end point(s): Progression-Free Survival (PFS) ;Timepoint(s) of evaluation of this end point: PFS will be defined as the number of days from date of randomization to the date of earliest disease progression or death.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival (OS) and objective response rate (ORR);Timepoint(s) of evaluation of this end point: OS will be defined as the number of days from the date of randomization to the date of death. ORR will be defined as the proportion of subjects with objective response.