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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 small molecule MEK inhibitor being studied for the treatment of rheumatoid arthritis and advanced solid tumors. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved by regulatory authorities.

What does ARRY-438162 target?

ARRY-438162 targets MEK, a kinase enzyme involved in cell signaling pathways that regulate cell growth and division. By inhibiting MEK, the drug aims to disrupt signaling that can drive inflammation and tumor growth, which is why it is being studied in rheumatoid arthritis and advanced solid tumors.

Who is developing ARRY-438162?

Pfizer, Inc. (NYSE: PFE) is the developer of ARRY-438162. The company has sponsored clinical trials of the drug in patients with rheumatoid arthritis and advanced solid tumors.

What phase is ARRY-438162 in?

ARRY-438162 has completed Phase 1 and Phase 2 clinical trials. The most advanced completed trial was a Phase 2 study in rheumatoid arthritis, while a Phase 1 study evaluated the drug in advanced solid tumors. The drug is investigational and not approved.

What clinical trials is ARRY-438162 in?

ARRY-438162 has been studied in two completed trials: NCT00650767, a Phase 2 study in rheumatoid arthritis with 201 participants, and NCT00959127, a Phase 1 study in advanced solid tumors with 93 participants. Both trials are completed, and no active trials are listed.

Is ARRY-438162 the same as MEK162?

Yes, ARRY-438162 is also known as MEK162. The Phase 1 trial in advanced solid tumors, NCT00959127, refers to the drug as ARRY-438162 (MEK162), confirming that these names refer to the same investigational MEK inhibitor.