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

Primary Purpose

Advanced Non-small Cell Lung Cancer, Transitional Cell Carcinoma, Soft Tissue Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
brivanib
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Of Chicago
  • Northshore Univ. Healthsystem
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Ctr
  • University Of Pennsylvania
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Radiographic imaging and clinical evaluation will be used for tumor assessment

Secondary Outcome Measures

Safety profiles
Disease response rate
Disease control rate
Pharmacokinetics
Pharmacodynamics
Biomarkers

Full Information

First Posted
March 5, 2008
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00633789
Brief Title
Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
Official Title
A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small Cell Lung Cancer, Transitional Cell Carcinoma, Soft Tissue Sarcoma, Gastric/Esophageal Adenocarcinoma, Pancreatic Cancer Including Ampulla of Vater

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 800 mg, once daily, until progression
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, once daily, until progression
Primary Outcome Measure Information:
Title
Radiographic imaging and clinical evaluation will be used for tumor assessment
Time Frame
every 6 weeks
Secondary Outcome Measure Information:
Title
Safety profiles
Time Frame
ongoing throughout trial
Title
Disease response rate
Time Frame
determined June 2010
Title
Disease control rate
Time Frame
determined June 2010
Title
Pharmacokinetics
Time Frame
determined June 2010
Title
Pharmacodynamics
Time Frame
determined June 2010
Title
Biomarkers
Time Frame
determined June 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Northshore Univ. Healthsystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1264
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1650
Country
Argentina
Facility Name
Local Institution
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution
City
Halle/saale
ZIP/Postal Code
06120
Country
Germany
Facility Name
Local Institution
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Local Institution
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution
City
Glasgow, Scotland
State/Province
Strathclyde
ZIP/Postal Code
GN11 6NT
Country
United Kingdom
Facility Name
Local Institution
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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