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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01046864
Phase
PHASE1
Status
Completed

Conditions

  • Gastro-Intestinal Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 28, 2010
Status verified
Sep 2014
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
  • Experimental: Arm 2
  • Experimental: Arm 3
    Japanese Population

Primary Outcome Measure

Safety-Toxicity, evaluated according to NCI Common Terminology Criteria for Adverse Events v3.0. Assessments based on medical review of adverse events, results of vital signs, ECGs, echocardiography, physical examinations, and clinical laboratory tests [ Time Frame: Cycle 4, Day 1 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Usc/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Texas OncologyDallasTexas75246-
Scott & White Memorial Hospital And ClinicTempleTexas76508-

Find similar trials in Los Angeles, CA

By research site
Usc/Norris Comprehensive Cancer Center· Los Angeles, CATexas Oncology· Dallas, TXScott & White Memorial Hospital And Clinic· Temple, TX

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