Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174863
First received: September 13, 2005
Last updated: December 22, 2008
Last verified: December 2008
  Purpose

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 Intervention Phase
Prostatic Neoplasm
Drug: SR31747A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • 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
  • Every 12 weeks: radiological examinations (tumor response),

Enrollment: 232
Study Start Date: October 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  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: 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
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174863     History of Changes
Other Study ID Numbers: EFC5378
Study First Received: September 13, 2005
Last Updated: December 22, 2008
Health Authority: Canada: Health Canada
Poland: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on November 20, 2014