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MK-4827

Phase 1

Solid Tumors | Small molecule | Oncology |GSK plc|Last Updated: Jul 25, 2013

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 Enrollment113
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00749502A Study of MK4827 in Participants With Advanced Solid Tumors or Hematologic Malignancies (MK-4827-001 AM8)PHASE1 COMPLETED 113Sep 1, 2008Jun 1, 2013Jul 25, 2013 -
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Study Endpoints
Primary Endpoints
Number of participants with dose limiting toxicities (DLTs)
Cycle 1 (21 days)
Percent inhibition of peripheral blood mononuclear cell PARP enzyme activity (Part A, B, and C)
Cycle 1 (Days 1-21)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A-Dose escalation and confirmationEXPERIMENTAL -
Part B - Prostate/Ovarian Cancer CohortEXPERIMENTAL -
Part C - T-PLL/CLL cohortEXPERIMENTAL -
Part D - CRC, endometrial, breast, and ovarian cancer cohortEXPERIMENTAL -
Interventions
NameTypeDescription
MK-4827DRUGMK-4827 in 10 mg and 100 mg capsules given daily in a 21 day dosing cycle (dose escalation to RP2D).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion criteria: * For Part A, participants must have a cytologically- or histologically-confirmed metastatic or locally advanced solid tumor for which standard therapy does not exist or the participants have refused standard therapy. * For Part B, participants must have a cytologically- or hist...

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