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| Descriptive Information Fields | |||||||||
| Brief Title † | Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer | ||||||||
| Official Title † | An Open-Label, Multicenter, Phase I/II Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer (HRPC) | ||||||||
| Brief Summary | This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen, |
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| Detailed Description | |||||||||
| Study Phase | Phase I, Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment | ||||||||
| Primary Outcome Measure † | Safety of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Preliminary efficacy of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Prostate Cancer | ||||||||
| Intervention † | Drug: AT-101 Drug: Docetaxel Drug: Prednisone |
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| MEDLINE PMIDs | |||||||||
| Links | Ascenta - Clinical Trials ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 75 | ||||||||
| Start Date † | February 2006 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00286793 | ||||||||
| Organization ID | AT-101-CS-202 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Ascenta Therapeutics | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Ascenta Therapeutics | ||||||||
| Verification Date | September 2008 | ||||||||
| First Received Date † | February 3, 2006 | ||||||||
| Last Updated Date | November 25, 2008 | ||||||||