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MK-1496

Phase 1

Neoplasms | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: Feb 19, 2015

MK-1496 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2009

MK-1496 target and mechanism

Molecular targetPLK1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

MK-1496 clinical trials

MK-1496 · 1 trial · 2 indications

Phase 1 1
NCT00880568Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)Neoplasms
COMPLETED27 Analytics
PHASE1COMPLETED
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose-limiting Toxicities (DLTs)
Cycle 1 (up to 21 or 28 days, depending on treatment arm)

Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.

Number of Participants With Any Clinical or Laboratory Adverse Event
First dose up to 30 days after last dose (up to 2 years)

This is a measure of the number of participants who experienced any adverse event (AE) while on study.

Secondary Endpoints

Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)
Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)
Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)
Cycle 1, Day 3 (Hour 0 through Hour 24)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-1496 20 mg (21-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
MK-1496 40 mg (21-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
MK-1496 80 mg (21-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
MK-1496 120 mg (21-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
MK-1496 20 mg (28-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 40 mg (28-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 80 mg (28-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 100 mg (28-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 120 mg (28-Day Cycle)EXPERIMENTALParticipants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Interventions

NameTypeDescription
MK-1496DRUGMK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria * Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. * Participant must have Performance Status 0 or 1. * Pa...

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Frequently asked questions about MK-1496

What is MK-1496?

MK-1496 is an investigational small molecule drug being developed by Merck & Company, Inc. for the treatment of neoplasms, including advanced solid tumors. It is designed as an inhibitor of PLK1 and has been studied in a Phase 1 clinical trial. MK-1496 has not been approved by the FDA and remains in clinical development.

What does MK-1496 target?

MK-1496 targets PLK1, also known as polo-like kinase 1. It acts as an inhibitor of this molecular target. PLK1 is involved in cell cycle regulation, and inhibiting it is being explored as an anticancer strategy in oncology. MK-1496 is a small molecule developed by Merck for advanced solid tumors.

Who makes MK-1496?

MK-1496 is made by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the developer of this investigational small molecule PLK1 inhibitor. The company has conducted clinical testing of MK-1496 in patients with advanced solid tumors.

What phase is MK-1496 in?

MK-1496 is in Phase 1 clinical development. It has been evaluated in a single completed Phase 1 trial. The drug is investigational and has not been approved by the FDA for any indication. Merck & Company, Inc. is the developer.

What clinical trials is MK-1496 in?

MK-1496 has been studied in one clinical trial, NCT00880568, titled Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4). This Phase 1 trial is completed and enrolled 27 participants with malignant neoplasms. It was a controlled study without randomization or double-blinding.