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MK2206 every other day

Phase 1

Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Sep 7, 2015

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01071018A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)PHASE1 COMPLETED 24Feb 1, 2010Sep 1, 2011Sep 7, 2015 -
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Study Endpoints
Primary Endpoints
Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)
Day 1 - Day 28 (Cycle 1)
Secondary Endpoints
Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax
Day 1 - Day 28 (Cycle 1)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
QOD ScheduleEXPERIMENTALQOD Schedule, MK2206 every other day
QW ScheduleEXPERIMENTALQW Schedule, MK2206 once weekly
Interventions
NameTypeDescription
MK2206 every other dayDRUGDose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles.
MK2206 once weeklyDRUGDose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles.
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy * Has adequate organ function * Is ECOG Performance Scale 0-1 * Has a negative urine pregnancy te...

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