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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00633789 |
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
Condition | Intervention | Phase |
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Advanced Non-Small Cell Lung Cancer Transitional Cell Carcinoma Soft Tissue Sarcoma Gastric/Esophageal Adenocarcinoma Pancreatic Cancer Including Ampulla of Vater |
Drug: brivanib Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors |
Estimated Enrollment: | 300 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: brivanib
Tablets, Oral, 800 mg, once daily, until progression
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2: Placebo Comparator |
Drug: Placebo
Tablets, Oral, 0 mg, once daily, until progression
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
Medical History and Concurrent Diseases:
Allergies and Adverse Drug Reactions:
Prohibited Treatments and/or Therapies:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA182-026 |
Study First Received: | March 5, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00633789 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Thoracic Neoplasms Pancreatic Neoplasms Carcinoma, Transitional Cell Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Respiratory Tract Diseases Lung Neoplasms Endocrine Gland Neoplasms Digestive System Neoplasms Endocrine System Diseases Carcinoma Malignant Mesenchymal Tumor Digestive System Diseases |
Esophageal Disorder Lung Diseases Sarcoma Gastrointestinal Neoplasms Pancreatic Diseases Non-small Cell Lung Cancer Esophageal Diseases Endocrinopathy Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Pancreatic Neoplasms Endocrine System Diseases Carcinoma, Transitional Cell Carcinoma Neoplasms, Connective and Soft Tissue Neoplasms Digestive System Diseases |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Sarcoma Pancreatic Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Endocrine Gland Neoplasms Neoplasms, Glandular and Epithelial |