Loading clinical trials...

Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

NCT00633789•Bristol-Myers Squibb

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
•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

Exclusion Criteria

•Subjects with known brain metastasis.
•Medical History and Concurrent Diseases:
•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
•Allergies and Adverse Drug Reactions:
•History of allergy to brivanib its drug class, or related compounds
•Prohibited Treatments and/or Therapies:
•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
+1 more criteria

Locations (25)

University Of Chicago

Chicago, Illinois, United States

Northshore Univ. Healthsystem

Evanston, Illinois, United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Ctr

New York, New York, United States

University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Key Dates

Start Date

June 1, 2008

Primary Completion Date

February 1, 2012

Completion Date

December 1, 2012

Last Updated

October 9, 2015

Enrollment

597

ACTUAL participants

Conditions

Advanced Non-small Cell Lung CancerTransitional Cell CarcinomaSoft Tissue SarcomaGastric/Esophageal AdenocarcinomaPancreatic Cancer Including Ampulla of Vater

Interventions

brivanib

DRUG

Placebo

DRUG

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

View study

RECRUITINGPHASE1

Actinium Therapy for Late-stage Aggressive Sarcomas

NCT07156565

Advanced Soft Tissue Sarcoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Actinium Therapy for Late-stage Aggressive Sarcomas

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients