Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer

NCT ID: NCT00723086

Last Updated: 2009-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Therapy, Prostatic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

docetaxel (XRP6976)

combined treatment with prednisolone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sanofi-aventis

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanofi-Aventis Administrative Office

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XRP6976J/2102

Identifier Type: -

Identifier Source: secondary_id

ARD6563

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.