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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633789
• Other study ID #: CA182-026
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2008
• Last updated: September 23, 2015
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Inclusion Criteria:

• 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.

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

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

• Prior exposure to brivanib

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• brivanib
Tablets, Oral, 800 mg, once daily, until progression
• Placebo
Tablets, Oral, 0 mg, once daily, until progression

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Belgium	Local Institution	Brussel
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Bruxelles
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Toronto	Ontario
France	Local Institution	Paris
France	Local Institution	Paris Cedex 13
Germany	Local Institution	Freiburg
Germany	Local Institution	Halle/saale
Netherlands	Local Institution	Maastricht
Netherlands	Local Institution	Rotterdam
Netherlands	Local Institution	Utrecht
Poland	Local Institution	Gdansk
United Kingdom	Local Institution	Glasgow, Scotland	Strathclyde
United Kingdom	Local Institution	Surrey
United States	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland
United States	University Of Chicago	Chicago	Illinois
United States	Northshore Univ. Healthsystem	Evanston	Illinois
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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  France,  Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic imaging and clinical evaluation will be used for tumor assessment		every 6 weeks	No
Secondary	Safety profiles		ongoing throughout trial	Yes
Secondary	Disease response rate		determined June 2010	No
Secondary	Disease control rate		determined June 2010	No
Secondary	Pharmacokinetics		determined June 2010	No
Secondary	Pharmacodynamics		determined June 2010	No
Secondary	Biomarkers		determined June 2010	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form