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estramustine

Phase 2

Hormone Resistant Prostate Cancer | Small molecule | Oncology |Sanofi|Last Updated: Oct 27, 2009

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00541281Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic CancerPHASE2 COMPLETED 150Dec 1, 2003Feb 1, 2006Oct 27, 200919 Belgium, Luxembourg
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Study Endpoints
Primary Endpoints
To compare the efficacy of the association of Docetaxel and Estramustineand Prednisone versus Docetaxel and Prednisone in the treatment of hormone refractory prostate cancer in terms o PSA response
within 30 days after end of treatment
Secondary Endpoints
PSA response Time to PSA progression PSA response duration Event Progression-Free Survival Overall survival Palliative response (Pain) Safety Objective response measurable disease (RECIST)
untill death occurs
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AACTIVE_COMPARATORweekly docetaxel and prednisone
BACTIVE_COMPARATORweekly docetaxel (35mg/m\&) plus prednisone 10mg a day associated with estramustine form day 1to 5 and 8 to 12
Interventions
NameTypeDescription
docetaxelDRUG35mg/m² on day 2 and 9 (21days in a cycle)
estramustineDRUG140mg caps x3 bid from day 1to 5 and day 8 to 12 of each cycle
prednisoneDRUG2x5 mg a day
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Signed informed consent prior to beginning protocol specific procedures. * 18 years * Histologically/cytologically proven prostate adenocarcinoma. * Documented metastatic prostate adenocarcinoma * Patients must have received prior hormonal therapy as defined below: * Castratio...

Countries:BelgiumLuxembourg
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