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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00174863




Registration number
NCT00174863
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
23/12/2008

Titles & IDs
Public title
Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
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
Secondary ID [1] 0 0
EFC5378
Universal Trial Number (UTN)
Trial acronym
ODYSSEY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR31747A

Treatment: Drugs: SR31747A
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Every 12 weeks: radiological examinations (tumor response),
Timepoint [2] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
Sample size
Target
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Diegem
Country [2] 0 0
Canada
State/province [2] 0 0
Laval
Country [3] 0 0
Chile
State/province [3] 0 0
Santiago
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Praha
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Italy
State/province [6] 0 0
Milano
Country [7] 0 0
Mexico
State/province [7] 0 0
Mexico
Country [8] 0 0
Netherlands
State/province [8] 0 0
Gouda
Country [9] 0 0
Poland
State/province [9] 0 0
Warszawa
Country [10] 0 0
Portugal
State/province [10] 0 0
Porto Salvo
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Guilford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00174863
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
B. TOMBAL, MD
Address 0 0
UCL St Luc, Bruxelles BELGIUM
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries