Phase II Study of Brivanib (BMS-582664) to Treat Multiple... | NCT00633789

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

NCT00633789

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 9, 2015Estimated

Enrollment

597Actual

Phase

Phase 2

Conditions

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

Interventions

brivanib
Placebo

Countries

United States
Argentina
Belgium
Canada
France
Germany
Netherlands
Poland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Feb 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 5, 2008

First Submission Date that Met QC Criteria

Mar 11, 2008

First Posted Date

Mar 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 23, 2015

Certification/Extension First Submitted that Passed QC Review

Sep 23, 2015

Certification/Extension First Posted Date

Oct 9, 2015Estimated

Last Update Submitted Date

Sep 23, 2015

Last Update Posted Date

Oct 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

597Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: brivanib
2	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
brivanib	Drug	Tablets, Oral, 800 mg, once daily, until progression	1

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

Measure	Description	Time Frame
Safety profiles		ongoing throughout trial
Disease response rate		determined June 2010
Disease control rate

Eligibility Module

Eligibility 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.

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University Of Chicago		Chicago	Illinois	60637	United States
Northshore Univ. Healthsystem

ID	Term
D002295	Carcinoma, Transitional Cell
D012509	Sarcoma
C562730	Adenocarcinoma Of Esophagus

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018204	Neoplasms, Connective and Soft Tissue