Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
NCT ID: NCT00174863
Last Updated: 2008-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
232 participants
INTERVENTIONAL
2003-10-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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SR31747A
Eligibility Criteria
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Inclusion Criteria
* Rising PSA while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; PSA must be at least 4ng/ml at the time of study entry.
* No distant metastases as evidenced by bone scan (+ or - centered X-Ray or MRI), and spiral thoracoabdominopelvic CT scan.
* Effective castration throughout the study. Any prior anti-androgen therapy should be stopped with documented continued elevation of PSA 4 weeks after the cessation of flutamide (6 weeks for bicalutamide).
* Serum testosterone levels \< 50ng/dL at the time of progression and throughout the study.
* Age \> or = to 18 years.
* Extensive metabolizer by CYP2D6 genotyping.
* Karnofsky Performance Status \> or = to 70% and life expectancy \> 6 months.
* Adequate hematological, renal and liver function.
* Signed written informed consent
Exclusion Criteria
* Prior palliative radiotherapy or any prior chemotherapy or experimental therapy.
* More than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry.
* Concomitant administration of biphosphonate or chronic corticosteroids.
* Presence of progressive symptoms not adequately controlled with non opioid medications
* Concomitant use of medications known to be cytochrome P450 2D6 inhibitors as listed in protocol appendice
* Previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer
* Other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.
18 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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B. TOMBAL, MD
Role: STUDY_CHAIR
UCL St Luc, Bruxelles BELGIUM
Locations
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sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Guilford Surrey, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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EFC5378
Identifier Type: -
Identifier Source: org_study_id