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ARD6562, Docetaxel

Phase 2

Prostatic Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Mar 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00291005PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With PrednisolonePHASE2 COMPLETED 42Aug 1, 2004 -Mar 27, 20091 Japan
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Study Endpoints
Primary Endpoints
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Secondary Endpoints
Overall response rate by modified WHO criteria, PSA response rate, safety
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ARD6562, DocetaxelDRUG -
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Eligibility Criteria
Age Range20 Years — 74 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy. Exclusion Criteria: * 1.Body temperature \> 38 degree centigrade. * 2.Prior radiotherapy to \> 25% of bone marrow. * 3.Prior isotope ther...

Countries:Japan
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