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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

597 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT00888173

Endometrial Adenocarcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Mixed Adenocarcinoma +6 more

COMPLETED PHASE2

BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer

NCT00006086

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

NCT03136627

Carcinoma, Renal Cell

COMPLETED PHASE1/PHASE2

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

NCT05868629

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

RECRUITING

Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors

NCT02867592

Adrenal Cortical Carcinoma Alveolar Soft Part Sarcoma Central Nervous System Neoplasm +41 more

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

brivanib

Intervention Type DRUG

Tablets, Oral, 800 mg, once daily, until progression

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, 0 mg, once daily, until progression

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

brivanib

Tablets, Oral, 800 mg, once daily, until progression

Intervention Type DRUG

Placebo

Tablets, Oral, 0 mg, once daily, until progression

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BMS-582664

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No