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: Active

Description

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 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.

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Los Angeles
Translational Oncology Research International
Status: Active
Contact: Kim Kelly
Phone: 310-206-8309
Email: kmkelly@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Rabia Rehman
Phone: 323-865-0460
Email: rabia.rehman@med.usc.edu
Rancho Cucamonga
City of Hope Rancho Cucamonga
Status: Active
Name Not Available
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Nebraska

Omaha
University of Nebraska Medical Center
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Approved
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: In review
Name Not Available

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Marcella West Aguilar
Phone: 214-648-1479
Email: marcella.aguilar@utsouthwestern.edu

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Approved
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

Primary ID M14-064
Secondary IDs NCI-2018-01058, 2017-003669-87
Clinicaltrials.gov ID NCT03368859