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

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Gastro-Intestinal Cancer
Interventions
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

Trial Locations (6)

75246

Texas Oncology, Dallas

76508

Scott & White Memorial Hospital And Clinic, Temple

90033

Usc/Norris Comprehensive Cancer Center, Los Angeles

94800

Local Institution, Villejuif

T6G 1Z2

Local Institution, Edmonton

K1H 8L6

Local Institution, Ottawa

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT01046864 - Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI) | Biotech Hunter | Biotech Hunter