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Sponsored by: |
Ascenta Therapeutics |
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Information provided by: | Ascenta Therapeutics |
ClinicalTrials.gov Identifier: | NCT00286793 |
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 |
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: | 75 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Hot Springs, Arkansas, United States | |
United States, Florida | |
Fort Meyers, Florida, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Minnesota | |
Fridley, Minnesota, United States | |
United States, New Mexico | |
Albuquerque, New Mexico, United States | |
United States, New York | |
Syracuse, New York, United States | |
United States, North Carolina | |
Wilmington, North Carolina, United States | |
United States, Oregon | |
Portland, Oregon, United States | |
United States, South Carolina | |
Hilton Head Island, South Carolina, United States | |
United States, Tennessee | |
Memphis, Tennessee, United States | |
Nashville, Tennessee, United States | |
Germantown, Tennessee, United States | |
United States, Texas | |
Richardson, Texas, United States |
Study Director: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
Responsible Party: | Ascenta Therapeutics ( Kimberli Brill, Associate Director, Clinical Development ) |
Study ID Numbers: | AT-101-CS-202 |
Study First Received: | February 3, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00286793 |
Health Authority: | United States: Food and Drug Administration |
at-101 at101 cancer hormone refractory |
prostate docetaxel prednisone |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Gossypol acetic acid Prostatic Neoplasms Gossypol |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents Contraceptive Agents, Male |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antispermatogenic Agents Antineoplastic Agents, Phytogenic Spermatocidal Agents |