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CP-675,206 and leuprolide and bicalutamide

Phase 1

Prostatic Neoplasms | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 6, 2012

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00075192CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate CancerPHASE1 COMPLETED 8 — — Mar 1, 2004Mar 1, 2006Jun 6, 201211 United States
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Study Endpoints
Primary Endpoints
Assess safety of combination therapy and effectiveness as assessed by pathological response after 3 months of treatment follow for disease status for a maximum of 24 months
Secondary Endpoints
assess Pk during treatment monitor for human anti-human antibodies at the end of the study explore genetic influences on safety and/or immune response
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CP-675,206 and leuprolide acetate and bicalutamideDRUG -
leuprolide acetate and bicalutamideDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate, previously untreated * Potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy * Potential candidate for NHT prior to prostatectomy, ...

Countries:United States
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