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Sponsored by: |
Ascenta Therapeutics |
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Information provided by: | Ascenta Therapeutics |
ClinicalTrials.gov Identifier: | NCT00571675 |
This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.
Condition | Intervention | Phase |
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Hormone Refractory Prostate Cancer |
Drug: AT-101, prednisone and docetaxel Drug: placebo, prednisone and docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC) |
Estimated Enrollment: | 180 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AT-101, prednisone and docetaxel
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Drug: AT-101, prednisone and docetaxel
docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3
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2: Placebo Comparator
Placebo, prednisone and docetaxel
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Drug: placebo, prednisone and docetaxel
docetaxel (75mg/m2 intravenously over 1 hour every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3
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Further Study Details provided by Ascenta.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Progression of disease despite androgen deprivation (androgen ablation or surgical castration) and anti-androgen withdrawal as documented by one or more of the following.
Rising PSA, as defined by increasing levels on at least two consecutive assessments, following a prior assessment taken as a reference value, where all of the following are met:
Exclusion Criteria:
Contact: Melissa Brookes | 610-408-0301 | mbrookes@ascenta.com |
Contact: Lance Leopold, MD | 610-408-0301 | lleopold@ascenta.com |
Study Director: | Lance Leopold, MD | Ascenta Therapeutics |
Responsible Party: | Ascenta Therapeutics ( Melissa Brookes, Sr. Project Manager, Clinical Development ) |
Study ID Numbers: | AT-101-CS-205 |
Study First Received: | December 11, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00571675 |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer Hormone Refractory Prostate Cancer HRPC Docetaxel |
Taxotere Prednisone Metastatic (Stage IV) Disease Chemotherapy-naïve metastatic Hormone Refractory Prostate Cancer (HRPC) |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Gossypol acetic acid Prostatic Neoplasms Gossypol |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive 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 |