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Iressa

Phase 2

Locally Advanced Prostate Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 25, 2011

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 Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00319787Combination Casodex® and Iressa™ in Locally Advanced Prostate CancerPHASE2 COMPLETED 102 — — Dec 1, 2003Aug 1, 2006Jan 25, 20113 Norway
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Study Endpoints
Primary Endpoints
Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Secondary Endpoints
To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS)
To detect changes in prostate gland using magnetic resonance imaging (MRI)
To detect changes in serum tumor markers
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
IressaDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma Exclusion Criteria: * No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malig...

Countries:Norway
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