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

March 26, 2009 updated by: Sanofi

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

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Chair: Atsushi NAKAMURA, CSD, PL / TA-Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

March 27, 2009

Last Update Submitted That Met QC Criteria

March 26, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARD6562
  • XRP6976J/2101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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