Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
Status: | Completed |
---|---|
Conditions: | Colorectal Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 9/28/2017 |
Start Date: | December 2, 2014 |
End Date: | September 21, 2017 |
Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI ± Bevacizumab Versus Placebo Plus FOLFIRI ± Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
This study seeks to evaluate the efficacy and tolerability of veliparib in combination with
FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or
rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan.
This is a blinded study such that the Investigator and Subject will be blinded but AbbVie
will be unblinded.
FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or
rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan.
This is a blinded study such that the Investigator and Subject will be blinded but AbbVie
will be unblinded.
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 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 colorectal cancer recurrence
- 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
We found this trial at
9
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
609 North Charles Richard Beall Boulevard
DeBary, Florida 32713
DeBary, Florida 32713
Click here to add this to my saved trials
Click here to add this to my saved trials
600 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials