Phase II Study Of Brivanib (BMS-582664) To Treat Multiple Tumor Types

Study Overview

Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types

The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib

N/A

Advanced Non-small Cell Lung Cancer
Transitional Cell Carcinoma
Soft Tissue Sarcoma
Gastric/Esophageal Adenocarcinoma
Pancreatic Cancer Including Ampulla of Vater

DRUG: brivanib
DRUG: Placebo

CA182-026

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-03-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-09-23
First Submitted that Met QC Criteria 2008-03-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-10-09
First Posted (ESTIMATED) 2008-03-12	Results First Posted N/A	Last Verified 2015-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1	DRUG: brivanib Tablets, Oral, 800 mg, once daily, until progression
PLACEBO_COMPARATOR: 2	DRUG: Placebo Tablets, Oral, 0 mg, once daily, until progression

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

DRUG: brivanib

Tablets, Oral, 800 mg, once daily, until progression

PLACEBO_COMPARATOR: 2

DRUG: Placebo

Tablets, Oral, 0 mg, once daily, until progression

Primary Outcome Measures	Measure Description	Time Frame
Radiographic imaging and clinical evaluation will be used for tumor assessment		every 6 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Safety profiles		ongoing throughout trial
Disease response rate		determined June 2010
Disease control rate		determined June 2010
Pharmacokinetics		determined June 2010
Pharmacodynamics		determined June 2010
Biomarkers		determined June 2010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Life expectancy at least 3 months
Diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. The initial enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla of Vater tumors
Adequate tumor sample
Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery or radiation therapy

Subjects with known brain metastasis.
Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI

History of thrombo-embolic disease within the last six months requiring therapeutic anticoagulation
Subjects with history of poor wound healing or non healing ulcers
Uncontrolled or significant cardiovascular disease

History of allergy to brivanib its drug class, or related compounds

Exposure to any investigational drug within 4 weeks of enrollment
Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiotherapy, standard or investigational. Subjects may continue to receive hormone replacement therapy
Prior exposure to brivanib

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

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Clinical Trial Record