Phase 2
Completed N=130
Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
Untreated Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT02305758 ↗
Enrolled (actual)
130
Serious AEs
48.5%
Results posted
Nov 2018
Primary outcomePrimary: Progression-Free Survival (PFS): Time to Event — 221; 213; 361; 337 days
Summary
This was a blinded, randomized, placebo-controlled Phase 2 multicenter study evaluating the efficacy and tolerability of veliparib plus irinotecan, fluorouracil, and leucovorin chemotherapy regimen (FOLFIRI) compared to placebo plus FOLFIRI in participants with previously untreated metastatic colorectal cancer. Participants could also have been treated with bevacizumab at the discretion of the Investigator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS): Time to Event |
221; 213; 361; 337; 534; 512 | — |
| SECONDARY Overall Survival (OS): Time to Event |
557; 512; 770; 811; NA; NA | — |
| SECONDARY Objective Response Rate (ORR) |
37; 40 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
- At least 1 unresectable lesion on a CT (Computerized Tomography) scan that is measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
- ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1
- Adequate hematologic, renal and hepatic function
Exclusion Criteria
- Prior anti-cancer treatment for metastatic colorectal cancer
- Prior exposure to PARP (poly ADP-ribose polymerase) inhibitors
- The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to Cycle 1 Day -2
- Any clinically significant and uncontrolled major medical condition
- Participant is pregnant or lactating
- Any medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicities
- For those receiving bevacizumab, standard medical exclusionary conditions apply
Data sourced from ClinicalTrials.gov (NCT02305758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.