Phase 3 Study of FOLFIRI Alone or With Napabucasin for Metastatic Colorectal Cancer

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)¹

Principal Investigator: Boston Biomedical, Inc.

Description: For this randomized phase 3 study (ClinicalTrials.gov Identifier: NCT02753127), researchers are comparing the efficacy of 5-FU, leucovorin, irinotecan (FOLFIRI) plus napabucasin with that of FOLFIRI alone in patients with previously treated metastatic colorectal cancer.

On day 1, patients in the FOLFIRI arm will receive intravenous (IV) irinotecan 180 mg/m² and leucovorin 400 mg/m², following bevacizumab 5mg/kg in select patients. IV 5-FU 400 mg/m² bolus will be administered immediately after irinotecan/leucovorin, followed by 5-FU 1200 mg/m² daily for 2 days. The treatment cycle will be repeated every 2 weeks.

Patients in the experimental arm will receive oral napabucasin 240 mg twice daily in addition to the treatment described for the control arm.

The primary outcome is overall survival.

The estimated study enrollment is 1250 patients.

For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/study/NCT02753127.

Status: Open and recruiting patients as of February 22, 2018.

This study is sponsored by Boston Biomedical, Inc.

Reference

1. ClinicalTrials.gov. A study of napabucasin (BBI-608) in combination with FOLFIRI in adult patients with previously treated metastatic colorectal cancer (CanStem303C). NCT02753127. https://clinicaltrials.gov/ct2/show/study/NCT02753127. Accessed February 22, 2018.