|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Ascenta Therapeutics |
|---|---|
| Information provided by: | Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00571675 |
Purpose
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 |
|---|---|---|
|
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: | 220 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
AT-101, prednisone and docetaxel
|
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
|
|
2: Placebo Comparator
Placebo, prednisone and docetaxel
|
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
|
Further Study Details provided by Ascenta.
Eligibility| 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:
Contacts and Locations
Show 43 Study Locations| Study Director: | Lance Leopold, MD | Ascenta Therapeutics |
More Information
| 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: | October 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00571675 History of Changes |
| 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) |
|
Anti-Inflammatory Agents Prednisone Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Contraceptive Agents, Male Hormones |
Docetaxel Neoplasms by Site Therapeutic Uses Antispermatogenic Agents Antineoplastic Agents, Hormonal Genital Diseases, Male Gossypol acetic acid Glucocorticoids Pharmacologic Actions Neoplasms Antineoplastic Agents, Phytogenic Prostatic Neoplasms Spermatocidal Agents |