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AZD0530

Phase 2

Ovarian Neoplasms | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Dec 18, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment211
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00610714AZD0530 Phase II Study in Patients With Advanced Ovarian CancerPHASE2 COMPLETED 211 — — Apr 1, 2008Jan 1, 2012Dec 18, 201250 Bulgaria, Canada +10
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Study Endpoints
Primary Endpoints
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)

Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.

Secondary Endpoints
Progression-free Survival (PFS) as Evaluated by RECIST
Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)
Overall Survival (Number of Deaths)
Date of randomization to death due to any cause
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active ComparatorACTIVE_COMPARATORcarboplatin plus paclitaxel
2EXPERIMENTALAZD0530 in combination with carboplatin plus paclitaxel
Interventions
NameTypeDescription
AZD0530DRUGoral once daily dose
CarboplatinDRUGintravenous injection
PaclitaxelDRUGintravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Have a diagnosis of advanced ovarian cancer * Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy * Estimated life expectancy of more than 12 weeks Exclusion Criteria: * Central Ner...

Countries:BulgariaCanadaDenmarkFranceNetherlandsNorwayPeruPortugalRomaniaRussiaSpainUnited Kingdom
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