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

Sanofi1 site in 1 country42 target enrollmentAugust 2004

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostatic Neoplasms
Sponsor: Sanofi
Enrollment: 42
Locations: 1
Primary Endpoint: Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Status: Completed
Last Updated: 17 years ago

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

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Sponsor

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

•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.