Back to resultsPhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ARD6562, Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostate cancer, HRPC, AIPC, Hormone refractory, Androgen independent, Docetaxel, Taxotere, prednisolone
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00291005
Brief Title
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostate cancer, HRPC, AIPC, Hormone refractory, Androgen independent, Docetaxel, Taxotere, prednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ARD6562, Docetaxel
Primary Outcome Measure Information:
Title
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Secondary Outcome Measure Information:
Title
Overall response rate by modified WHO criteria, PSA response rate, safety
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atsushi NAKAMURA
Organizational Affiliation
CSD, PL / TA-Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
We'll reach out to this number within 24 hrs