NCT01776307

A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.

Detailed description

This is an open label, multi-center, Phase 2 study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	BBI608	BBI608 is administered at 500 mg po bid continuously.
DRUG	Panitumumab	Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.
DRUG	Capecitabine	Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.
DRUG	Cetuximab	Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-06-01
• Completion: 2020-04-01
• First posted: 2013-01-28
• Last updated: 2023-11-15
• Results posted: 2021-06-18

Locations

13 sites across 1 country: United States