NCT01046864

Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI)

A Phase Ib Multiple Ascending Dose Study to Evaluate the Safety of Brivanib in Combination With 5-Fluorouracil/Leucovorin (5FU/LV) and Brivanib in Combination With 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI) in Subjects With Advanced or Metastatic Gastrointestinal Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.

Conditions

• Gastro-Intestinal Cancer

Interventions

Type	Name	Description
DRUG	5-FU	IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity
DRUG	Leucovorin	IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity
DRUG	5-FU	IV solution, IV infusion over 46 hours, 2400 mg/m², Every 14 days, Until disease progression/toxicity
DRUG	Irinotecan	IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity
DRUG	Brivanib	Tablets, Oral, 400 - 800 mg, once daily, Until disease progression/toxicity
DRUG	Brivanib	Tablets, Oral, 600 - 800 mg, once daily, Until disease progression/toxicity
DRUG	Brivanib	Tablets, Oral, 800 mg, once daily, Until disease progression/toxicity

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-01-12
• Last updated: 2014-09-16

Locations

6 sites across 3 countries: United States, Canada, France