NCT01124630

Study of CS-1008 in Combination With FOLFIRI in Patients Who Have Failed Other Treatments

Pilot Study of CS-1008 in Combination With FOLFIRI (Irinotecan, Leucovorin, and 5-fluorouracil [5-FU]) in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Failed First-line Treatment That Was Not Irinotecan-based.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Treatment with CS-1008 in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluorouracil \[5-FU\]) in subjects with metastatic colorectal cancer (CRC) who have failed first-line treatment that was not irinotecan-based.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CS-1008	CS-1008 will be administered IV each week. The initial/loading dose (6 mg/kg) will be administered Day 1 of Cycle 1. Maintenance doses of 2 mg/kg will be administered weekly thereafter.
DRUG	FOLFIRI	The FOLFIRI regimen will be administered IV at Weeks 1 and 3 of each 4 week cycle, and it will begin at Week 1 of Cycle 1. It will comprise irinotecan, 180 mg/m2 IV infusion over 30 to 120 minutes; leucovorin, 400 mg/m2 IV infusion to match the duration of the irinotecan infusion; and 5-FU, 400 mg/m2 (bolus) followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46 to 48 hours continuous infusion).

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2010-05-17
• Last updated: 2013-12-03

Locations

3 sites across 1 country: United States