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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.


Phase 2
N/A
N/A
Not Enrolling
Male
Therapy, Prostatic Neoplasms

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0)

Outcome Time Frame:

First treatment up to 37 months

Safety Issue:

Yes

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

ARD6563

NCT ID:

NCT00723086

Start Date:

May 2005

Completion Date:

September 2008

Related Keywords:

  • Therapy, Prostatic Neoplasms
  • docetaxel, prednisolone, drug combination
  • Neoplasms
  • Prostatic Neoplasms

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