A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Official Title

A Phase III Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).

Summary:

This is an international multi-centre, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

Trial Description

Primary Outcome:

  • Overall Survival
Secondary Outcome:
  • Overall Survival in biomarker positive patients
  • Progression Free Survival
  • Progression Free Survival in biomarker positive patients
  • Objective Response Rate
  • Disease Control Rate
  • Objective Response Rate in biomarker positive patients
  • Disease Control Rate in biomarker positive patients
  • Number of Patients with Adverse Events
  • Quality of Life (QoL)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society