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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00174863
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer ODYSSEY
• Scientific 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
• Date of first enrolment: October 2003
• Target sample size: 232
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00174863
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, Chile, Czech Republic, France, Italy, Mexico, Netherlands, Poland, Portugal, Spain, United Kingdom

Contacts

• Name: B. TOMBAL, MD
• Affiliation: UCL St Luc, Bruxelles BELGIUM

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasm

Intervention(s)

Drug: SR31747A

Primary Outcome(s)

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(s)

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),

Secondary ID(s)

EFC5378

Source(s) of Monetary Support

Please refer to primary and secondary sponsors