Therapy, Prostatic Neoplasms Clinical Trial
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.
| Verified date | September 2009 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | September 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility |
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: - Continuation in the study would be detrimental to the patient's well-being - Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing - Obvious disease progression (rising prostate specific antigen, any increase of = 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion) - Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Sanofi-Aventis Administrative Office | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0) | First treatment up to 37 months | Yes | |
| Secondary | No obvious disease progression | First treatment up to 37 months | No |