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Completed

NCT Number: NCT01046864

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

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.

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Key information

Conditions

Gastro-Intestinal Cancer Digestive System Diseases Gastric Outlet Obstruction Gastrointestinal Diseases Pyloric Stenosis Pyloric Stenosis, Hypertrophic Stomach Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Histological/cytological confirmed diagnosis of Gastrointestinal malignancy, except pancreatic cancer
  • Eligible for 5FU/LV or FOLFIRI chemotherapy
  • ECOG 0-1
  • Able to swallow and tolerate tablets
  • Life expectancy of 3 months

Exclusion criteria

  • Unwilling to use acceptable method to avoid pregnancy of partner/self for the entire study period and up to 4 weeks after last dose
  • Women who are pregnant or breastfeeding
  • Pancreatic cancer
  • Known brain metastasis, evidence of leptomeningeal disease
  • History of thrombo-embolic disease
  • Hemorrhage/bleeding events
  • Uncontrolled or significant cardiovascular disease
  • Any 3 or more of the following risk factors: arterial thrombosis , smoking, hypercholesterolemia, hypertension, obesity (BMS>30) and diabetes
  • Pre-existing thyroid abnormality, not maintained with medication
  • QTC (Fridericia) >450 msec on two consecutive ECG's
  • Subjects with concomitant second malignancies ( except adequately treated non-melanoma skin, in situ carcinoma of bladder, cervix or breast, early prostate cancer)
  • Any major surgery within 4 weeks of study drug administration
  • Increased levels of both D-Dimer and Prothrombin fragment 1 +2
  • Arm B and C only-positive UGT1A1 genotype of TA7/TA7
  • History of allergy of brivanib or drug class
  • History of severe reactions to fluoropyrimidine therapy or irinotecan
  • Prior therapy with brivanib

Treatment and study plan

5-FU

Drug

IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity

Other names: Fluorouracil

Leucovorin

Drug

IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity

Other names: Folinic acid

Irinotecan

Drug

IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity

Other names: Camptosar

Brivanib

Drug

Tablets, Oral, 400 - 800 mg, once daily, Until disease progression/toxicity

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacokinetics (Cmax, Tmax, AUC (TAU), T-HALF) plasma concentration vs time for brivanib given alone and in combination with FOLFIRI. Individual concentrations (C) of 5FU will be calculated from samples on Day 2 in the presence and absence of Brivanib

    Time frame: Cycle 2, Day 2

  2. Efficacy-Tumor BOR determined for treated subjects by radiological responses assessed by CT scan or MRI, by RECIST criteria (v1.1). Radiological tumor assessments to evaluate response & progression will be done every 8 wks or more frequently if indicated

    Time frame: Every 8 weeks

  3. Exploratory Measures (Biomarkers for Predictive Analysis): Potential predictive markers, including activity of FGF, VEGF and related pathways as well as K-RAS mutation status, will be evaluated based on blood or tumor samples

    Time frame: Cycle 1, Cycle 2, every other cycle

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 12, 2010
Registry last updated
Sep 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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