Overview

A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer

Status:
Unknown status

Trial end date:
2021-11-01

Target enrollment:

Participant gender:

Summary

This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. For patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with FOLFIRI to patients randomized to Arm 1.

Phase:

Phase 3

Details

Lead Sponsor:

1Globe Biomedical Co., Ltd.
1Globe Health Institute LLC

Treatments:

Camptothecin
Fluorouracil
Irinotecan
Leucovorin