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

Study Overview
=================
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

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

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

Intervention / Treatment
-----------------
* Drug: brivanib
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: brivanib<br>* Tablets, Oral, 800 mg, once daily, until progression<br>* Other names: BMS-582664;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Tablets, Oral, 0 mg, once daily, until progression<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profiles |  | ongoing throughout trial | 
| Disease response rate |  | determined June 2010 | 
| Disease control rate |  | determined June 2010 | 
| Pharmacokinetics |  | determined June 2010 | 
| Pharmacodynamics |  | determined June 2010 | 
| Biomarkers |  | determined June 2010 |