Status:
TERMINATED
A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Lead Sponsor:
AbbVie
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
Eligibility Criteria
Inclusion
- Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- Primary tumor has been resected \> 3 months prior to randomization.
- At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.
- Adequate hematologic, renal and hepatic function.
Exclusion
- Any prior therapy with irinotecan
- Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) =\> Grade 2
- Clinically significant conditions that increase the risk for antiangiogenic therapy.
- History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03368859
Start Date
March 20 2018
End Date
December 18 2019
Last Update
February 9 2021
Active Locations (65)
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1
Ironwood Cancer & Res Ctr /ID# 200044
Chandler, Arizona, United States, 85224-5665
2
Highlands Oncology Group /ID# 169289
Fayetteville, Arkansas, United States, 72703-4005
3
City of Hope /ID# 200501
Duarte, California, United States, 91010
4
St. Joseph Heritage Healthcare /ID# 200100
Fullerton, California, United States, 92835