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

Prostatic Neoplasm Clinical Trial

— ODYSSEY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174863
• Other study ID #: EFC5378
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: December 22, 2008
• Start date: October 2003
• Est. completion date: August 2006

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaPoland: Ministry of HealthBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• SR31747A

Locations

Country	Name	City	State
Australia	sanofi-aventis Australia & New Zealand administrative office	Macquarie Park	New South Wales
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Italy	Sanofi-Aventis Administrative Office	Milano
Mexico	Sanofi-Aventis Administrative Office	Mexico
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Poland	Sanofi-Aventis Administrative Office	Warszawa
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Spain	Sanofi-Aventis Administrative Office	Barcelona
United Kingdom	Sanofi-Aventis Administrative Office	Guilford Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Every 12 weeks: radiological examinations (tumor response),

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