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| Sponsored by: |
Ascenta Therapeutics |
| Information provided by: | Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00286793 |
Purpose
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,
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: AT-101 Drug: Docetaxel Drug: Prednisone |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| ChemIDplus related topics: | Docetaxel Prednisone |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| 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) |
| Estimated Enrollment: | 65 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kimberli Brill, BSN | (610) 408-0301 | kbrill@ascenta.com |
| Contact: Lance Leopold, MD | (610) 408-0301 | lleopold@ascenta.com |
| United States, Arkansas | |||||
| Recruiting | |||||
| Hot Springs, Arkansas, United States | |||||
| United States, Florida | |||||
| Recruiting | |||||
| Fort Meyers, Florida, United States | |||||
| United States, Illinois | |||||
| Recruiting | |||||
| Chicago, Illinois, United States | |||||
| United States, Minnesota | |||||
| Recruiting | |||||
| Fridley, Minnesota, United States | |||||
| United States, New Mexico | |||||
| Recruiting | |||||
| Albuquerque, New Mexico, United States | |||||
| United States, New York | |||||
| Recruiting | |||||
| Syracuse, New York, United States | |||||
| United States, North Carolina | |||||
| Recruiting | |||||
| Wilmington, North Carolina, United States | |||||
| United States, Oregon | |||||
| Recruiting | |||||
| Portland, Oregon, United States | |||||
| United States, South Carolina | |||||
| Recruiting | |||||
| Hilton Head Island, South Carolina, United States | |||||
| United States, Tennessee | |||||
| Recruiting | |||||
| Memphis, Tennessee, United States | |||||
| Recruiting | |||||
| Nashville, Tennessee, United States | |||||
| Recruiting | |||||
| Germantown, Tennessee, United States | |||||
| United States, Texas | |||||
| Recruiting | |||||
| Richardson, Texas, United States | |||||
| Ascenta Therapeutics |
| Study Director: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
More Information
Ascenta - Clinical Trials 
  |
| Responsible Party: | Ascenta Therapeutics ( Kimberli Brill, Associate Director, Clinical Development ) |
| Study ID Numbers: | AT-101-CS-202 |
| First Received: | February 3, 2006 |
| Last Updated: | April 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00286793 |
| Health Authority: | United States: Food and Drug Administration |
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