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MK-4827

Phase 1

Recurrence of Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 15, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01294735Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)PHASE1 COMPLETED 19Feb 1, 2011May 1, 2012Aug 15, 2012 -
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Study Endpoints
Primary Endpoints
Number of participants with DLTs
Cycle 1 (28 days)
Secondary Endpoints
Number of participants with an objective response rate of partial or complete response
Baseline, Day 25 of each cycle, within 30 days of last dose, and at 2 month intervals until disease progression or new therapy initiated.
Number of participants with 6-month progression-free survival
6 months from baseline imaging
Progression-Free Survival (PFS)
First dose to progressive disease or death, whichever occurs first
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A, MK-4827 + temozolomide dose escalation cohortEXPERIMENTAL -
Part B, MK-4827 + temozolomide melanoma cohortEXPERIMENTAL -
Part B, MK-4827 + temozolomide glioblastoma multiforme cohortEXPERIMENTAL -
Interventions
NameTypeDescription
MK-4827DRUGMK-4827 in combination with temozolomide utilizing a number of doses and schedules for both drugs will be explored to determine a preliminary MTD. The preliminary MTD will then be confirmed in participants with melanoma and glioblastoma multiforme.
TemozolomideDRUGMK-4827 in combination with temozolomide utilizing a number of doses and schedules for both drugs will be explored to determine a preliminary MTD. The preliminary MTD will then be confirmed in participants with melanoma and glioblastoma multiforme.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion criteria Part A * Participants with histologically-confirmed advanced solid tumors who have failed to respond to standard therapy, or progressed on standard therapy, or for whom standard therapy does not exist. Part B * Participants must have a histologically-confirmed recurrent gliobl...

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