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MK-1496

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

MK-1496 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed by Merck & Company, Inc. for use in oncology, specifically targeting malignant neoplasms, which are cancers.

Who makes MK-1496?

MK-1496 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical research to evaluate the safety and efficacy of this investigational oncology drug.

What phase is MK-1496 in?

MK-1496 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a study in patients with advanced solid tumors. As an investigational drug, it is not yet approved by regulatory authorities and remains in clinical testing.

What clinical trials is MK-1496 in?

MK-1496 has one completed clinical trial registered as NCT00880568. This was a Phase 1 study in patients with advanced solid tumors, enrolling 27 participants aged 18 years and older. The trial was controlled but not randomized or double-blinded, and it has been completed.

How does MK-1496 work?

MK-1496 is a small molecule, but its specific molecular target has not been disclosed in available information. As an investigational oncology drug, it is being studied for its potential to treat malignant neoplasms, though the exact mechanism of action is not publicly detailed.