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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00723086 |
The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.
Condition | Intervention | Phase |
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Therapy, Prostatic Neoplasms |
Drug: docetaxel (XRP6976) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Extension Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer. |
Estimated Enrollment: | 42 |
Study Start Date: | May 2005 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment.
Exclusion Criteria:
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | ARD6563, XRP6976J/2102 |
Study First Received: | July 24, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00723086 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
docetaxel, prednisolone, drug combination |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Methylprednisolone Prednisolone Methylprednisolone acetate |
Prednisolone acetate Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Protective Agents Neuroprotective Agents |
Glucocorticoids Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |