M14-064-ABT165

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

Objective

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.

Study Arms

  • Experimental: ABT-165 plus FOLFIRI
  • Active Comparator: Bevacizumab plus FOLFIRI

Eligibility

  • Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
  • 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

NCT ID

NCT03368859