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OpenTrials
Completed

NCT Number: NCT00291005

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

* 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

Completed

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

20 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARD6562, Docetaxel

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2004
First posted
Feb 13, 2006
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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