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Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer (ODYSSEY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00174863
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 23, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Drug: SR31747A Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study
Study Start Date : October 2003
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Time To Clinical Progression assessed by every 4 weeks clinical examination and every 12 weeks radiological examinations (Thoraco-abdominopelvic CT scan ; Bone scan ± centered Bone X-rays, MRI)

Secondary Outcome Measures :
  1. Every 4 weeks: Clinical examination (safety, Tumor related symptoms deterioration), PSA level determination (PSA endpoints), EuroQoL instrument (Quality of Life), Laboratory tests (Hematology, Biochemistry), one PK sample
  2. Every 12 weeks: radiological examinations (tumor response),


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior confirmed histological diagnosis of prostatic carcinoma.
  • 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:

  • Poor metabolizers by CYP2D6 genotyping.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174863


Locations
Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
France
Sanofi-Aventis Administrative Office
Paris, France
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guilford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: B. TOMBAL, MD UCL St Luc, Bruxelles BELGIUM

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174863     History of Changes
Other Study ID Numbers: EFC5378
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs