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

Official Title

A Phase 3 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, adaptive design 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:
  • Progression Free Survival in the General Population and pSTAT3(+) Subpopulation
  • Objective Response Rate in the General Population and pSTAT3(+) Subpopulation
  • Disease Control Rate in the General Population and pSTAT3(+) Subpopulation
  • Number of Patients with Adverse Events in the General Population and pSTAT3(+) Subpopulation
  • Quality of Life (QoL) in the General Population and pSTAT3(+) Subpopulation

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