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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


Phase 1
20 Years
75 Years
Open (Enrolling)
Both
Gastro-Intestinal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

Cycle 4, Day 1

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA182-046

NCT ID:

NCT01046864

Start Date:

February 2009

Completion Date:

July 2012

Related Keywords:

  • Gastro-Intestinal Cancer
  • Gastro-Intestinal Cancer, NOS
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Texas OncologyDallas, Texas  
Scott & White Memorial Hospital and ClinicTemple, Texas  76508