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

Previously Treated Metastatic Colorectal Cancer Clinical Trial

Official title: A Phase III, Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination With FOLFIRI Versus Napabucasin in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Previously Treated Metastatic Colorectal Cancer

• NCT number: NCT03522649
• Study type: Interventional
• Source: 1Globe Biomedical Co., Ltd.
• Contact: Liu Wang
• Phone: +86-10-62336199
• Email: wangliu@1globe-china.com
• Status: Recruiting
• Phase: Phase 3
• Start date: April 12, 2018
• Completion date: November 2021