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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00633789
Other study ID # CA182-026
Secondary ID
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


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
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