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ARRY-438162, MEK inhibitor · 2 trials · 4 indications
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.
| Arm | Type | Description |
|---|---|---|
| ARRY-438162 (Schedule 1) | EXPERIMENTAL | - |
| ARRY-438162 (Schedule 2) | EXPERIMENTAL | - |
| ARRY-438162 (Schedule 3) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ARRY-438162 (MEK 162) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ARRY-438162, MEK inhibitor; oral | DRUG | multiple dose, single schedule |
| Placebo; oral | DRUG | matching placebo |
| ARRY-438162 (MEK162), MEK inhibitor; oral | DRUG | Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule. |
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 ...
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ARRY-438162 is an investigational oral small molecule studied in advanced solid tumors, including advanced or metastatic biliary cancer and metastatic colorectal cancer, and in rheumatoid arthritis. It has been evaluated in Phase 1 oncology research and in a Phase 2 rheumatoid arthritis study, and it is not an approved therapy.
ARRY-438162 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The compound, also written as ARRY-438162 (MEK162), was studied by Pfizer in both oncology and rheumatoid arthritis settings.
ARRY-438162 has completed Phase 1 testing in advanced solid tumors and a Phase 2 study in rheumatoid arthritis. It remains an investigational agent rather than an approved medicine, and no trials of the drug are currently listed as active.
ARRY-438162 was studied in NCT00959127, a completed Phase 1 trial in patients with advanced cancer, including advanced or metastatic biliary cancer and metastatic colorectal cancer, that enrolled 93 participants in the United States. It was also studied in NCT00650767, a completed Phase 2 trial in rheumatoid arthritis that enrolled 201 participants across the United States, Argentina, Brazil, Hungary, Peru, Poland and Romania.
Yes. ARRY-438162 is also known as MEK162, and the two names refer to the same oral small molecule. It is described as a MEK inhibitor and has been studied under both designations in advanced solid tumors and rheumatoid arthritis.
Across the two completed studies of ARRY-438162, 294 participants have been enrolled. The Phase 1 advanced cancer trial NCT00959127 enrolled 93 patients, and the Phase 2 rheumatoid arthritis trial NCT00650767 enrolled 201 patients. Both studies enrolled adults aged 18 years and older.