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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00291005

First received: February 10, 2006

Last updated: March 26, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2006

Last Updated Date

March 26, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00291005 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Drug: ARD6562, Docetaxel

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

20 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00291005

Other Study ID Numbers ^ICMJE

ARD6562, XRP6976J/2101

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Atsushi NAKAMURA

CSD, PL / TA-Oncology

Information Provided By

Sanofi

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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