Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
Phase 2
Completed
- Conditions
- Prostatic Neoplasm
- Registration Number
- NCT00174863
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 232
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Every 12 weeks: radiological examinations (tumor response), 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
Trial Locations
- Locations (2)
Sanofi-Aventis Administrative Office
🇬🇧Guilford Surrey, United Kingdom
sanofi-aventis Australia & New Zealand administrative office
🇦🇺Macquarie Park, New South Wales, Australia