NCT02641873

A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

A Phase I Study of BBI608 Administered With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sumitomo Pharma Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI + Bavacizumab. This study population is adult Japanese patients with metastatic colorectal cancers in FOLFIRI + Bevacizumab combination therapy.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	BBI608	240 mg twice daily (480 mg total daily dose)
DRUG	5-FU	400 mg/m2 bolus will be administered intravenously immediately following irinotecan/levofolinate infusion, followed by 1200 mg/m2/day (total 2400 mg/m2) continuous infusion per cycle(14 days).
DRUG	Irinotecan	180 mg/m2 together with levofolinate will be administered intravenously per cycle(14 days).
DRUG	Levofolinate	200 mg/m2 together with Irinotecan will be administered intravenously per cycle(14 days).
DRUG	Bevacizumab	5 mg/kg will be administered intravenously following irinotecan/levofolinate infusion per cycle(14 days).

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2015-12-30
• Last updated: 2022-04-12

Locations

2 sites across 1 country: Japan