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Casodex

Phase 2

Gynaecomastia | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 24, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00637871Casodex - Nolvadex CombinationPHASE2 COMPLETED -Nov 1, 2002Aug 1, 2005Jan 24, 2011 -
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Study Endpoints
Secondary Endpoints
To describe the extent of gynaecomastia and breast pain by treatment group
To describe the relative change from baseline in sex hormones concentrations by treatment group
To describe the pharmacokinetics of tamoxifen, N-desmethyltamoxifen and R-bicalutamide when nolvadex is co-administered at varying doses with CASODEX 150 mg once daily
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
CasodexDRUG150mg once daily
TamoxifenDRUG -
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Eligibility Criteria
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically * Subjects in need of immediate hormonal therapy. * PSA equal or above 4 ng/ml Exclusion Cr...

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