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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

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

MK-4827 · 1 trial · 3 indications

Phase 1 1
NCT01294735Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)Recurrence of Solid Tumor
COMPLETED19 Analytics
PHASE1COMPLETED
Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)
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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 to 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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Frequently asked questions about MK-4827

What is MK-4827 used for?

MK-4827 is an investigational small molecule being studied for the treatment of recurrence of solid tumors, including glioblastoma multiforme and melanoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes MK-4827?

MK-4827 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials.

What phase is MK-4827 in?

MK-4827 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. One Phase 1 trial has been completed, and the drug is not yet available for commercial use.

What clinical trials is MK-4827 in?

MK-4827 has been studied in one clinical trial, identified as NCT01294735. This Phase 1 study, titled "Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)," has been completed and enrolled 19 participants.

Is MK-4827 the same as any other drug?

MK-4827 is not known to have alternative names. It is a distinct investigational compound developed by Merck & Company, Inc. for oncology indications, and no other names for this drug have been reported.