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SR31747A

Phase 2

Prostatic Neoplasm | Small molecule | Oncology |Sanofi|Last Updated: Dec 23, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment232
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00174863Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate CancerPHASE2 COMPLETED 232 — — Oct 1, 2003Aug 1, 2006Dec 23, 200813 Australia, Belgium +11
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Study Endpoints
Primary Endpoints
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 Endpoints
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),
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SR31747ADRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites13

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 tim...

Countries:AustraliaBelgiumCanadaChileCzechiaFranceItalyMexicoNetherlandsPolandPortugalSpainUnited Kingdom
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