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MK2461

Phase 1

Advanced Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 27, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00518739MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)PHASE1 COMPLETED 25Feb 1, 2007Dec 1, 2008Mar 27, 2015 -
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of MK2461
18 Months
Secondary Endpoints
To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics.
18 Months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
MK2461DRUGPatients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 \& beyond).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must be at least 18 years of age, with adequate organ function, and an ECOG performance of \<2 * Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A) Exclusion Criteria: * No chemotherapy...

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