A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

• Status: Terminated
• Trial end date: 2019-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Bevacizumab; Fluorouracil; Irinotecan; Leucovorin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.