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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: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00286793 History of Changes |
Health Authority: | United States: Food and Drug Administration |
at-101 at101 cancer hormone refractory |
prostate docetaxel prednisone |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Contraceptive Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Urogenital Neoplasms |
Genital Diseases, Male Contraceptive Agents, Male Glucocorticoids Hormones Gossypol acetic acid Gossypol Docetaxel Retinol acetate Antineoplastic Agents, Phytogenic Prostatic Neoplasms |
Anti-Inflammatory Agents Prednisone Prostatic Diseases Genital Neoplasms, Male Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Contraceptive Agents, Male Hormones Gossypol |
Docetaxel Neoplasms by Site Therapeutic Uses Antispermatogenic Agents Antineoplastic Agents, Hormonal Genital Diseases, Male Gossypol acetic acid Glucocorticoids Pharmacologic Actions Neoplasms Prostatic Neoplasms Antineoplastic Agents, Phytogenic Spermatocidal Agents |