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

Phase 2

Completed

• Conditions: Advanced Non-small Cell Lung Cancer; Pancreatic Cancer Including Ampulla of Vater; Transitional Cell Carcinoma; Gastric/Esophageal Adenocarcinoma; Soft Tissue Sarcoma
• Interventions: Drug: Placebo; Drug: brivanib

• Registration Number: NCT00633789
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Study Start: 2008-06
• Primary Completion: 2012-02
• Study Completion: 2012-12
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-09
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 597

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	brivanib	-

Primary Outcome Measures

Name	Time	Method
Radiographic imaging and clinical evaluation will be used for tumor assessment	every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Disease control rate	determined June 2010
Biomarkers	determined June 2010
Disease response rate	determined June 2010
Pharmacodynamics	determined June 2010
Pharmacokinetics	determined June 2010
Safety profiles	ongoing throughout trial

Trial Locations

Locations (7)

Local Institution; 🇬🇧 Surrey, United Kingdom

Memorial Sloan Kettering Cancer Ctr; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, 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

University Of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States