{"id":"binimetinib-only-treatment","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT02050815","NCT02613650","NCT05203172","NCT03915951","NCT04657991","NCT01885195","NCT03864042","NCT02928224","NCT04543188","NCT03693170","NCT01781572","NCT05926960","NCT04494958","NCT01909453","NCT04800822","NCT01649336","NCT01801358","NCT03170206","NCT01849874","NCT05097599","NCT03911869","NCT04585815","NCT01320085","NCT01556568","NCT00959127"],"aliases":[],"patents":[],"pricing":[],"allNames":"binimetinib only treatment","offLabel":[],"timeline":[{"date":"2013","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer) — Advanced Solid Tumors"},{"date":"2014","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma) — BRAF or NRAS Mutant Metastatic Melanoma"},{"date":"2016","type":"negative","milestone":"Phase 3 Initiated","description":"Phase 3 trial (A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fal) — Low-grade Serous Ovarian Cancer. Trial terminated early."},{"date":"2029","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo) — Solid Tumors"}],"aiSummary":"Binimetinib is a small molecule inhibitor of the dual specificity mitogen-activated protein kinase kinase 1 (MEK1) enzyme. It has been studied as a treatment for various conditions, including melanoma, gastrointestinal stromal tumor, and metastatic breast cancer, often in combination with other medications.","brandName":"Binimetinib only treatment","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Par","explanation":"Cancer cells often rely on a chain of molecular signals to grow and divide. One critical link in this chain is a protein called MEK. In certain cancers with specific mutations (like NRAS mutations), this MEK protein becomes overactive, constantly telling cells to multiply. Binimetinib acts as a brake on this system by binding to MEK and preventing it from passing along growth signals.\n\nWhen MEK is blocked, the cascade of commands that normally drives cell division gets interrupted. The cancer cells no longer receive the \"grow and divide\" message, so they stop proliferating. This is particularly effective in melanomas where NRAS mutations have already activated the growth pathway upstream of MEK, making this protein an ideal target in those specific patients.\n\nBy using this targeted approach, binimetinib attacks a specific vulnerability in certain cancers while potentially sparing some healthy cells that don't rely as heavily on this same pathway. This is why genetic testing is important—the drug works best in patients whose cancers actually have these MEK-dependent mutations.","oneSentence":"Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Par","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"binimetinib-only-treatment","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Solid Tumors","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02050815","phase":"Phase 1","title":"MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function","status":"Terminated","sponsor":"Array Biopharma, now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":27,"indication":"Hepatic Impairment","completionDate":"2016-08","primaryEndpoint":"This study is a phase I, multi-center, open-label, single oral dose, parallel group study to assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy subjects with nor"},{"nctId":"NCT02613650","phase":"Phase 1","title":"A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metasta","status":"Completed","sponsor":"University of Utah","isPivotal":false,"enrollment":25,"indication":"Advanced KRAS Positive Metastatic Colorectal Cancer","completionDate":"2022-11","primaryEndpoint":"This is a Phase 1b, open label, dose-finding study to determine the Maximum Tolerated Dose (MTD) of MEK162 in combination with mFOLFIRI, and to evaluate the response rate, clinical benefit rate and ad"},{"nctId":"NCT05203172","phase":"Phase 4","title":"The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo","status":"Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":46,"indication":"Solid Tumors","completionDate":"2029-07","primaryEndpoint":"The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib"},{"nctId":"NCT03915951","phase":"Phase 2","title":"An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lun","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":98,"indication":"Non-small Cell Lung Cancer","completionDate":"2022-09","primaryEndpoint":"This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mut"},{"nctId":"NCT04657991","phase":"Phase 3","title":"A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients ","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":257,"indication":"Melanoma","completionDate":"2026-01","primaryEndpoint":"The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metas"},{"nctId":"NCT01885195","phase":"Phase 2","title":"MEK162 for Patients With RAS/RAF/MEK Activated Tumors","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":110,"indication":"Solid Tumor and Hematologic Malignancies","completionDate":"2015-10","primaryEndpoint":"The purpose of this signal seeking study is to determine whether treatment with MEK162 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warr"},{"nctId":"NCT03864042","phase":"Phase 1","title":"Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patient","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":56,"indication":"Advanced Solid Tumors","completionDate":"2022-07","primaryEndpoint":"This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK)"},{"nctId":"NCT02928224","phase":"Phase 3","title":"Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":702,"indication":"BRAF V600E-mutant Metastatic Colorectal Cancer","completionDate":"2019-02","primaryEndpoint":"This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/"},{"nctId":"NCT04543188","phase":"Phase 1","title":"A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":65,"indication":"Malignant Melanoma","completionDate":"2024-03","primaryEndpoint":"First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced s"},{"nctId":"NCT03693170","phase":"Phase 2","title":"Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal ","status":"Completed","sponsor":"Pierre Fabre Medicament","isPivotal":false,"enrollment":95,"indication":"BRAF V600E-mutant Metastatic Colorectal Cancer","completionDate":"2020-06","primaryEndpoint":"The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal ca"},{"nctId":"NCT01781572","phase":"Phase 1/2","title":"A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":102,"indication":"Locally Advanced or Metastatic NRAS Mutant Melanoma","completionDate":"2018-01","primaryEndpoint":"In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination."},{"nctId":"NCT05926960","phase":"Phase 2","title":"A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":38,"indication":"Melanoma","completionDate":"2026-02","primaryEndpoint":"The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment "},{"nctId":"NCT04494958","phase":"Phase 1/2","title":"Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer","status":"Completed","sponsor":"Fundacion Oncosur","isPivotal":false,"enrollment":24,"indication":"Triple Negative Breast Cancer","completionDate":"2023-12","primaryEndpoint":"This study is an interventional, prospective, multicentric, single-arm, open label, phase Ib clinical trial."},{"nctId":"NCT01909453","phase":"Phase 3","title":"Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":921,"indication":"Melanoma","completionDate":"2016-11","primaryEndpoint":"This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with loc"},{"nctId":"NCT04800822","phase":"Phase 1","title":"PF-07284892 in Participants With Advanced Solid Tumors","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":53,"indication":"Solid Tumor","completionDate":"2024-06","primaryEndpoint":"The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lor"},{"nctId":"NCT01649336","phase":"Phase 1","title":"A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal C","status":"Completed","sponsor":"Array Biopharma, now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":36,"indication":"Epithelial Ovarian Cancer","completionDate":"2016-03","primaryEndpoint":"This is a Phase 1 study during which patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer will receive investigational study drug MEK162 and paclitaxel."},{"nctId":"NCT01801358","phase":"Phase 1/2","title":"A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma","status":"Terminated","sponsor":"Array Biopharma, now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":38,"indication":"Uveal Melanoma","completionDate":"2015-05","primaryEndpoint":"A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma."},{"nctId":"NCT03170206","phase":"Phase 1","title":"Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Smal","status":"Completed","sponsor":"Dana-Farber Cancer Institute","isPivotal":false,"enrollment":34,"indication":"Lung Cancer","completionDate":"2023-02","primaryEndpoint":"This trial is being conducted as a possible treatment for lung cancer with a specific change in the KRAS gene."},{"nctId":"NCT01849874","phase":"Phase 3","title":"A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fal","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":341,"indication":"Low-grade Serous Ovarian Cancer","completionDate":"2016-01","primaryEndpoint":"The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube o"},{"nctId":"NCT05097599","phase":"Phase 2","title":"StrataPATH™ (Precision Indications for Approved Therapies)","status":"Terminated","sponsor":"Strata Oncology","isPivotal":false,"enrollment":11,"indication":"Cancer","completionDate":"2024-06","primaryEndpoint":"StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populati"},{"nctId":"NCT03911869","phase":"Phase 2","title":"An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":13,"indication":"Brain Metastases","completionDate":"2022-01","primaryEndpoint":"This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV6"},{"nctId":"NCT04585815","phase":"Phase 1/2","title":"Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced N","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":34,"indication":"Carcinoma, Non-Small-Cell Lung","completionDate":"2023-05","primaryEndpoint":"Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study."},{"nctId":"NCT01320085","phase":"Phase 2","title":"A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":183,"indication":"BRAF or NRAS Mutant Metastatic Melanoma","completionDate":"2014-01","primaryEndpoint":"The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mu"},{"nctId":"NCT01556568","phase":"Phase 2","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophi","status":"Withdrawn","sponsor":"Array Biopharma, now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":0,"indication":"Cardiomegaly","completionDate":"2017-05","primaryEndpoint":"The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead to "},{"nctId":"NCT00959127","phase":"Phase 1","title":"A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer","status":"Completed","sponsor":"Array Biopharma, now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":93,"indication":"Advanced Solid Tumors","completionDate":"2013-01","primaryEndpoint":"This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162)."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL3187723"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":7,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}