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5-flourouracil

Phase 2

Squamous Cell Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 23, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00255476The IRESSA Novel Head and Neck Chemotherapy Evaluation StudyPHASE2 COMPLETED 64Feb 1, 2004Jul 1, 2007Apr 23, 20091 United Kingdom
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Study Endpoints
Primary Endpoints
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Secondary Endpoints
To compare safety and tolerability in these patients
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
gefitinibDRUG -
cisplatinDRUG -
5-flourouracilDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provision of written informed consent * Patients with histologically proven primary SCCHN * Aged 18 or over Exclusion Criteria: * Patients eligible for surgery with curative intent * Other co-existing malignancies diagnosed within the last 5 years with the exception of basal...

Countries:United Kingdom
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