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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291005
• Other study ID #: ARD6562
• Secondary ID: XRP6976J/2101
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2006
• Last updated: March 26, 2009
• Start date: August 2004

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• ARD6562, Docetaxel

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Secondary	Overall response rate by modified WHO criteria, PSA response rate, safety