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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
  Purpose
  • 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

Condition Intervention Phase
Prostatic Neoplasms
 Drug: ARD6562, Docetaxel
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)

Secondary Outcome Measures:
  • Overall response rate by modified WHO criteria, PSA response rate, safety

Estimated Enrollment: 42
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291005

Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Atsushi NAKAMURA CSD, PL / TA-Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00291005     History of Changes
Other Study ID Numbers: ARD6562, XRP6976J/2101
Study First Received: February 10, 2006
Last Updated: March 26, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
Prostate cancer
HRPC
AIPC
Hormone refractory
 Androgen independent
Docetaxel
Taxotere
prednisolone

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone acetate
Prednisolone acetate
 Docetaxel
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 21, 2013