Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

Official Title

Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

Keywords

Cancer colorectal cancer ABT-165 FOLFIRI Bevacizumab bowel cancer metastatic colorectal cancer metastatic colorectal Colorectal Neoplasms Oxaliplatin Irinotecan Fluorouracil Leucovorin Fluorouracil - bolus Fluorouracil - infusion ABT-165 plus FOLFIRI Bevacizumab plus FOLFIRI

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • UC Davis Comprehensive Cancer Center - Main /ID# 207227 accepting new patients
    Sacramento California 95817 United States
  • Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215 accepting new patients
    San Luis Obispo California 93401-7068 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Sign up for this study
ID
NCT03368859
Phase
Phase 2
Study Type
Interventional
Last Updated