PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00291005

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
To evaluate PSA (tumor marker) response rate
To evaluate safety

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: ARD6562, Docetaxel	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 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

Study Start Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST) []

Secondary Outcome Measures

Overall response rate by modified WHO criteria, PSA response rate, safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 74 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.

Exclusion Criteria:

1.Body temperature > 38 degree centigrade.
2.Prior radiotherapy to > 25% of bone marrow.
3.Prior isotope therapy and/or brachytherapy
4.Prior gene therapy.
5.Active double cancer.
6.Known brain or leptomeningeal involvement.
7.History of hypersensitivity reaction to drug
8.Other serious illness or medical condition
9.Subjects whom the investigators consider inappropriate from social or medical aspects.