NCT02851004

Special Combination of BBI608 and Pembrolizumab

A Phase Ib/II Study of BBI608 in Combination With Pembrolizumab in Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Takayuki Yoshino · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

the efficacy and safety of BBI608 in combination with pembrolizumab

Detailed description

This is a multicenter, open-label Phase Ib/II study to exploratively evaluate the efficacy and safety of BBI608 in combination with pembrolizumab in patients with metastatic colorectal cancer (CRC) not responded to or intolerant of standard chemotherapy.The same analysis will be performed for the additional cohort to the Phase II part, consisting of patients with metastatic CMS 1 or 4, MMS, CRC not responsive to or intolerant of standard chemotherapy.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Napabucasin	1 cycle is 21days. BBI608: Oral administration at a dose of 240mg or 480 mg twice daily (BID), every day. \[Additional cohort to the Phase II part\] Oral administration at a dose of 240mg mg BID, every day The therapy will be repeated until meeting the discontinuation criteria.
DRUG	Pembrolizumab	1 cycle is 21days. Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle \[Additional cohort to the Phase II part\] Administration at a dose of 200 mg/body on Day 1 of each cycle. The therapy will be repeated until meeting the discontinuation criteria.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-02-03
• Completion: 2021-08-23
• First posted: 2016-08-01
• Last updated: 2021-09-05

Locations

1 site across 1 country: Japan