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Aprepitant

Phase 2

Nausea and Vomiting | Small molecule | Other |GSK plc|Last Updated: May 10, 2010

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 Enrollment492
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00169572Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based ChemotherapyPHASE2 COMPLETED 492 — — Feb 1, 2005 -May 10, 201051 Argentina, Austria +17
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Study Endpoints
Primary Endpoints
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Secondary Endpoints
Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AprepitantDRUG -
OndansetronDRUG -
GW679769DRUG -
DexamethasoneDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion criteria: * Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments. * Diagnosed with a solid malignant tumour and has not previously received chemotherapy. * Scheduled to receive chemotherapy conducive to regimens outlined in the stud...

Countries:ArgentinaAustriaBelgiumChileCroatiaCzechiaHong KongHungaryItalyMexicoNetherlandsPakistanPeruPhilippinesPolandRomaniaSingaporeSlovakiaTaiwan
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