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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00744497 |
The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib in addition to docetaxel and prednisone.
Condition | Intervention | Phase |
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Prostatic Neoplasms |
Drug: placebo + docetaxel/prednisone Drug: dasatinib + docetaxel/prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Phase III Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer |
Estimated Enrollment: | 1380 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: placebo + docetaxel/prednisone
Tablets, Oral, 0 mg, Once daily, average 18 weeks, depending on response
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2: Active Comparator |
Drug: dasatinib + docetaxel/prednisone
Tablets, Oral, 100 mg, Once daily, average 18 weeks, depending on response
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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: | CA180-227 |
Study First Received: | August 29, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00744497 History of Changes |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: National Committee of Ethics in Research; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; India: Drugs Controller General of India; Ireland: Irish Medicines Board; Italy: Ministry of Health; Korea: Food and Drug Administration; Mexico: Federal Commission for Sanitary Risks Protection; Norway: The National Committees for Research Ethics in Norway; Peru: Health National Institute; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Russia: FSI Scientific Center of Expertise of Medical Application; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Anti-Inflammatory Agents Prednisone Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Protein Kinase Inhibitors Glucocorticoids Hormones Docetaxel Dasatinib Prostatic Neoplasms |
Anti-Inflammatory Agents Prednisone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Urogenital Neoplasms |
Genital Diseases, Male Protein Kinase Inhibitors Glucocorticoids Hormones Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Dasatinib Prostatic Neoplasms |