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MK0869, aprepitant / Duration of Treatment: 3 days

Phase 3

Nausea | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: May 5, 2017

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment820
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092196Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)PHASE3 COMPLETED 820Dec 1, 2002Dec 1, 2004May 5, 2017 -
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Study Endpoints
Primary Endpoints
Safety and tolerability
Secondary Endpoints
Assessment of adverse experiences using the National Cancer Institute (NCI) criteria
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
MK0869, aprepitant / Duration of Treatment: 3 daysDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. * Patient must have completed participation in the main study for this protocol. Exclusion Criteria: * Patient has a central nervous system malignancy. * Pati...

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