Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer
Tracking Information
Start Date ICMJE | October 2008 |
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Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 29, 2008) | Overall survival [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: August 29, 2008) | Overall survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ] |
Change History | Complete list of historical versions of study NCT00744497 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 16, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: August 29, 2008) |
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Descriptive Information
Brief Title ICMJE | Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer |
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Official Title ICMJE | A Randomized Double-Blind Phase III Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Prostatic Neoplasms |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1380 | ||||||||
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Estimated Completion Date | December 2012 | ||||||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Brazil, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Republic of, Mexico, Norway, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00744497 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CA180-227 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/