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ARRY-438162, MEK inhibitor

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Dec 1, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment201

FDA Designations

No designations recorded

Clinical trial landscape

ARRY-438162, MEK inhibitor · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT00650767A Study of ARRY-438162 in Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED201 Analytics
PHASE2COMPLETED
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

American College of Rheumatology 20% (ACR20) Response Rate at Week 12
Week 12

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Establish the maximum tolerated dose (MTD) of the study drug.
Part 1, one year
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Parts 1, 2 and 3: two years
Characterize the pharmacokinetics (PK) of the study drug and metabolite.
Parts 1, 2 and 3: two years

Secondary Endpoints

American College of Rheumatology 20% (ACR20) Response Rate at Week 1
Week 1
American College of Rheumatology 20% (ACR20) Response Rate at Week 2
Week 2
American College of Rheumatology 20% (ACR20) Response Rate at Week 4
Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARRY-438162 (Schedule 1)EXPERIMENTAL -
ARRY-438162 (Schedule 2)EXPERIMENTAL -
ARRY-438162 (Schedule 3)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ARRY-438162 (MEK 162)EXPERIMENTAL -

Interventions

NameTypeDescription
ARRY-438162, MEK inhibitor; oralDRUGmultiple dose, single schedule
Placebo; oralDRUGmatching placebo
ARRY-438162 (MEK162), MEK inhibitor; oralDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

Key Inclusion Criteria: * Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug. * Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue ...

Countries:United StatesArgentinaBrazilHungaryPeruPolandRomania
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Frequently asked questions about ARRY-438162, MEK inhibitor

What is ARRY-438162 used for?

ARRY-438162 is an investigational oral small molecule that has been studied in advanced solid tumors, including advanced or metastatic biliary cancer and metastatic colorectal cancer, and in rheumatoid arthritis. It is not approved for any indication and remains in clinical development.

What does ARRY-438162 target?

ARRY-438162 is a MEK inhibitor. It targets MEK, a kinase in the MAPK signaling pathway that transmits growth signals from RAS and RAF to ERK. By inhibiting MEK, the drug is designed to interrupt this signaling cascade in tumor cells.

Who makes ARRY-438162?

Pfizer, Inc. (ticker PFE) is the developer of ARRY-438162. The compound was originally discovered by Array BioPharma and later advanced by Pfizer, which holds the development program for this MEK inhibitor.

What phase is ARRY-438162 in?

ARRY-438162 is in Phase 1 development overall. A Phase 1 trial in advanced cancer has been completed, and a separate Phase 2 study in rheumatoid arthritis has also been completed. The drug is investigational and has not been approved by the FDA.

What clinical trials is ARRY-438162 in?

ARRY-438162 has been evaluated in two completed trials: NCT00959127, a Phase 1 study in patients with advanced cancer that enrolled 93 participants in the United States, and NCT00650767, a Phase 2 study in rheumatoid arthritis that enrolled 201 participants across the United States, Argentina, Brazil, Hungary, Peru, Poland, and Romania.

Is ARRY-438162 the same as MEK162?

Yes. ARRY-438162 is also known as MEK162. Both names refer to the same oral small molecule MEK inhibitor developed by Pfizer. The compound is sometimes described simply as a MEK inhibitor in study titles and publications.