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MEK162, MEK inhibitor

Phase 1

Epithelial Ovarian Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 14, 2020

Target and mechanism

Molecular targetMAP2K2, MAP2K1
Target classInhibitor
ModalitySmall molecule

Also known as Binimetinib, binimetinib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

MEK162, MEK inhibitor · 1 trial · 3 indications

Phase 1 1
NCT01649336A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal CancerEpithelial Ovarian Cancer
COMPLETED36 Analytics
PHASE1COMPLETED
A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Epithelial Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel.
One year

Secondary Endpoints

Characterize the safety profile of the study drug in combination with paclitaxel in terms of adverse events and clinical laboratory tests.
One year
Assess the efficacy of the study drug in combination with paclitaxel in terms of tumor response, duration of response and progression-free survival.
One year
Assess the potential plasma pharmacokinetic (PK) interactions between study drug, metabolites and paclitaxel in terms of plasma concentrations and noncompartmental PK parameters.
One year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEK162 + paclitaxelEXPERIMENTAL -

Interventions

NameTypeDescription
MEK162, MEK inhibitor; oralDRUGmultiple dose, escalating
Paclitaxel, mitotic inhibitor; intravenousDRUGmultiple dose, single schedule
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Histologically confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer (measurable or evaluable, nonmeasurable disease) that is platinum-resistant or refractory. In the judgment of the Investigator, a patient who is platinum-sensitive but wou...

Countries:United States
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Frequently asked questions about MEK162, MEK inhibitor

What is Binimetinib used for?

Binimetinib is an investigational small molecule kinase inhibitor being studied in oncology. It is being evaluated for epithelial ovarian cancer, advanced solid tumors, metastatic colorectal cancer, advanced KRAS positive metastatic colorectal cancer, BRAF or NRAS mutant metastatic melanoma, and melanoma stage III. It is currently in Phase 2 clinical development.

What does Binimetinib target?

Binimetinib is a kinase inhibitor, belonging to the -tinib class of drugs. It targets MEK, a kinase in the RAS/RAF/MEK/ERK pathway. By inhibiting MEK, it is designed to block signaling that drives tumor growth in cancers with RAS or BRAF mutations.

Who makes Binimetinib?

Binimetinib is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for multiple oncology indications.

What phase is Binimetinib in?

Binimetinib is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It is being studied across multiple oncology indications, including advanced solid tumors and metastatic colorectal cancer.

What clinical trials is Binimetinib in?

Binimetinib has been studied in several clinical trials. NCT01352273 was a Phase 1 trial in advanced solid tumors with RAS or BRAFV600E mutations. NCT01649336 was a Phase 1 trial in ovarian, fallopian tube, or peritoneal cancer. NCT01763164 was a Phase 3 trial in NRAS-mutant melanoma. NCT03271047 is a Phase 2 trial in MSS, RAS-mutant colorectal cancer.

Is Binimetinib the same as MEK162?

Yes, Binimetinib is also known as MEK162. Clinical trials such as NCT01352273 and NCT01649336 refer to the drug as MEK162. This alternative name is used in research settings and historical trial documentation.