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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
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisolone
Methylprednisolone Hemisuccinate
Hormones
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisolone acetate
Methylprednisolone acetate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 19, 2017