Clinical Trials

Numerous clinical trials evaluate binimetinib across diverse oncological indications, including BRAF V600-mutant melanoma, non-small cell lung cancer, colorectal cancer, metastatic breast cancer, and pediatric adamantinous craniopharyngioma. Encompassing phase 1 through phase 4 investigations, recruitment statuses for these studies range from recruiting and active not recruiting to completed or terminated. These trials, which examine both targeted and combination therapies, are sponsored by academic institutions, government organizations like the National Cancer Institute, and pharmaceutical companies such as Pfizer and Pierre Fabre Medicament.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07092410 WITHDRAWN
Melanoma BRAF V600E/K Mutated
SRH Wald-Klinikum Gera GmbH
 2025-08 PHASE4
NCT05564377 RECRUITING
Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2023-04-07 PHASE2
NCT05203172 RECRUITING
Solid Tumors
Pfizer
 2022-07-05 PHASE4
NCT06207656 RECRUITING
Colorectal Cancer
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
 2024-04-16 PHASE2
NCT04913285 RECRUITING
Solid Tumor, Adult; Non-small Cell Lung Cancer; Melanoma
Pierre Fabre Medicament
 2021-08-04 PHASE1
NCT05554367 ACTIVE_NOT_RECRUITING
Exocrine Pancreas Carcinoma; Malignant Solid Neoplasm; Ovarian Low Grade Serous Adenocarcinoma; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
National Cancer Institute (NCI)
 2023-12-13 PHASE2
NCT04903119 RECRUITING
Metastatic Melanoma; BRAF Gene Mutation
Rina Plattner
 2022-06-01 PHASE1
NCT04322383 RECRUITING
Hairy Cell Leukemia
National Cancer Institute (NCI)
 2021-01-07 PHASE2
NCT06887088 RECRUITING
Melanoma BRAF V600E/K Mutated; Melanoma and Brain Metastases
Grupo Español Multidisciplinar de Melanoma
 2025-05-29 PHASE2
NCT04061980 ACTIVE_NOT_RECRUITING
BRAF NP_004324.2:p.V600M; BRAF V600E Mutation Present; Metastatic Thyroid Gland Carcinoma; Refractory Thyroid Gland Carcinoma; Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8; Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8; Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
Providence Health & Services
 2020-10-30 PHASE2
NCT02910700 ACTIVE_NOT_RECRUITING
Metastatic Malignant Neoplasm in the Brain; Metastatic Melanoma; Stage III Cutaneous Melanoma AJCC v7; Stage IIIA Cutaneous Melanoma AJCC v7; Stage IIIB Cutaneous Melanoma AJCC v7; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Melanoma
M.D. Anderson Cancer Center
 2016-12-09 PHASE2
NCT05355701 ACTIVE_NOT_RECRUITING
Melanoma; Non-Small-Cell Lung Cancer; Thyroid Cancer; Glioma; Advanced Colorectal Cancer (Part 1)
Pfizer
 2022-07-05 PHASE1
NCT04511013 RECRUITING
Acral Lentiginous Melanoma; Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Cutaneous Melanoma; Metastatic Malignant Neoplasm in the Brain; Metastatic Melanoma; Metastatic Mucosal Melanoma; Pathologic Stage IV Cutaneous Melanoma AJCC v8
SWOG Cancer Research Network
 2021-01-06 PHASE2
NCT05615818 RECRUITING
Biliary Tract Neoplasms
UNICANCER
 2024-07-18 PHASE3
NCT04598009 RECRUITING
Melanoma Stage III; Melanoma Stage IV
University of California, San Francisco
 2021-03-03 PHASE2
NCT05286788 RECRUITING
Adamantinous Craniopharyngioma; Recurrent Adamantinomatous Craniopharyngioma
Nationwide Children's Hospital
 2023-04-10 PHASE2
NCT05270044 ACTIVE_NOT_RECRUITING
Melanoma
Pierre Fabre Medicament
 2022-05-02 PHASE3
NCT05111561 RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Triple-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2022-08-02 PHASE1
NCT06159478 RECRUITING
Low-grade Glioma; Pancreatic Cancer
National Cancer Center, Japan
 2023-03-29 PHASE2
NCT05026983 RECRUITING
Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Pathologic Stage IV Cutaneous Melanoma AJCC v8
M.D. Anderson Cancer Center
 2021-12-27 PHASE2
NCT03971409 ACTIVE_NOT_RECRUITING
Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Invasive Breast Carcinoma; Recurrent Breast Carcinoma; Triple-Negative Breast Carcinoma; Unresectable Breast Carcinoma
Laura Huppert, MD, BA
 2019-07-08 PHASE2
NCT03947385 RECRUITING
Metastatic Uveal Melanoma; Cutaneous Melanoma; Colorectal Cancer; Other Solid Tumors
IDEAYA Biosciences
 2019-06-28 PHASE1; PHASE2
NCT02465060 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma
National Cancer Institute (NCI)
 2015-08-17 PHASE2
NCT03803553 RECRUITING
Metastatic Colon Cancer; Stage III Colon Cancer
Massachusetts General Hospital
 2020-04-16 PHASE3
NCT03839342 ACTIVE_NOT_RECRUITING
Solid Tumor
University Health Network, Toronto
 2019-06-07 PHASE2
NCT01991379 ACTIVE_NOT_RECRUITING
Gastrointestinal Stromal Tumor (GIST)
Memorial Sloan Kettering Cancer Center
 2013-11 PHASE1; PHASE2
NCT04657991 ACTIVE_NOT_RECRUITING
Melanoma
Pfizer
 2021-01-15 PHASE3
NCT05564403 ACTIVE_NOT_RECRUITING
Advanced Biliary Tract Carcinoma; Advanced Gallbladder Carcinoma; Advanced Intrahepatic Cholangiocarcinoma; Recurrent Biliary Tract Carcinoma; Recurrent Gallbladder Carcinoma; Recurrent Intrahepatic Cholangiocarcinoma; Stage III Distal Bile Duct Cancer AJCC v8; Stage III Gallbladder Cancer AJCC v8; Stage III Hilar Cholangiocarcinoma AJCC v8; Stage III Intrahepatic Cholangiocarcinoma AJCC v8; Stage IV Distal Bile Duct Cancer AJCC v8; Stage IV Gallbladder Cancer AJCC v8; Stage IV Hilar Cholangiocarcinoma AJCC v8; Stage IV Intrahepatic Cholangiocarcinoma AJCC v8; Unresectable Biliary Tract Carcinoma; Unresectable Gallbladder Carcinoma; Unresectable Intrahepatic Cholangiocarcinoma
National Cancer Institute (NCI)
 2024-02-09 PHASE2
NCT03991819 ACTIVE_NOT_RECRUITING
Non-small Cell Carcinoma
University Health Network, Toronto
 2019-09-20 PHASE1
NCT04741997 RECRUITING
Melanoma Stage III; Melanoma Stage IV; BRAF V600 Mutation
H. Lee Moffitt Cancer Center and Research Institute
 2021-05-24 EARLY_PHASE1
NCT04324112 ACTIVE_NOT_RECRUITING
Hairy Cell Leukemia
National Cancer Institute (NCI)
 2020-10-28 PHASE2
NCT04074096 ACTIVE_NOT_RECRUITING
Malignant Melanoma; BRAF V600 Mutation; Brain Metastases
UNICANCER
 2022-09-05 PHASE2
NCT04892017 TERMINATED
Non-Small Cell Lung Cancer; Advanced Solid Tumor; Metastatic Solid Tumor
Deciphera Pharmaceuticals, LLC
 2021-06-15 PHASE1
NCT04132505 COMPLETED
Metastatic Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8
M.D. Anderson Cancer Center
 2019-10-22 PHASE1
NCT05926960 TERMINATED
Melanoma
Pfizer
 2023-06-13 PHASE2
NCT05767879 UNKNOWN
Melanoma Stage III; In-Transit Metastasis of Cutaneous Melanoma
Leiden University Medical Center
 2022-01-01 PHASE2
NCT05170334 ACTIVE_NOT_RECRUITING
Metastatic Uveal Melanoma
H. Lee Moffitt Cancer Center and Research Institute
 2021-12-15 PHASE2
NCT05080621 WITHDRAWN
Gastrointestinal Stromal Tumors
Deciphera Pharmaceuticals, LLC
 2021-11 PHASE1; PHASE2
NCT04870034 WITHDRAWN
Colorectal Carcinoma; Lung Adenocarcinoma; Malignant Solid Neoplasm; Pancreatic Carcinoma
Roswell Park Cancer Institute
 2024-01-15 EARLY_PHASE1
NCT05304546 COMPLETED
Malignant Melanoma; Metastatic Melanoma; Immunotherapy; BRAF V600E; Malignant Melanoma Stage IV
Dr. Ronnie Shapira
 2023-09-05 PHASE2
NCT04526782 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; BRAF V600E
Intergroupe Francophone de Cancerologie Thoracique
 2021-01-19 PHASE2
NCT05554354 TERMINATED
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic HER2-Negative Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma
National Cancer Institute (NCI)
 2024-09-13 PHASE2
NCT05340621 COMPLETED
RAS Mutation; NRAS Gene Mutation; Melanoma
OnKure, Inc.
 2022-05-11 PHASE1; PHASE2
NCT03543969 ACTIVE_NOT_RECRUITING
Melanoma (Skin); Skin Cancer; Skin Melanoma; Skin Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
 2018-06-14 EARLY_PHASE1
NCT04720768 UNKNOWN
Melanoma; Metastasis
Peter MacCallum Cancer Centre, Australia
 2020-06-04 PHASE1; PHASE2
NCT04375527 TERMINATED
Clinical Stage III Cutaneous Melanoma AJCC V8; Clinical Stage IV Cutaneous Melanoma AJCC V8; Locally Advanced Cutaneous Melanoma; Metastatic Cutaneous Melanoma; Pathologic Stage III Cutaneous Melanoma AJCC V8; Pathologic Stage IIIA Cutaneous Melanoma AJCC V8; Pathologic Stage IIIB Cutaneous Melanoma AJCC V8; Pathologic Stage IIIC Cutaneous Melanoma AJCC V8; Pathologic Stage IIID Cutaneous Melanoma AJCC V8; Pathologic Stage IV Cutaneous Melanoma AJCC V8; Unresectable Cutaneous Melanoma
Jonsson Comprehensive Cancer Center
 2020-12-03 PHASE2
NCT05510895 COMPLETED
Colorectal Cancer; Colon Cancer; BRAF V600E; BRAF V600 Mutation; Localized Cancer
AIO-Studien-gGmbH
 2022-09-01 PHASE2
NCT04800822 TERMINATED
Solid Tumor
Pfizer
 2021-03-17 PHASE1
NCT05097599 TERMINATED
Cancer; Advanced Solid Tumor
Strata Oncology
 2022-04-29 PHASE2
NCT04221438 TERMINATED
Melanoma of Unknown Primary; Metastatic Malignant Neoplasm in Lymph Node; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8; Recurrent Cutaneous Melanoma
ECOG-ACRIN Cancer Research Group
 2021-09-22 PHASE2
NCT03563729 RECRUITING
Malignant Melanoma
Inge Marie Svane
 2018-06-06 PHASE2
NCT02631447 COMPLETED
Metastatic Melanoma
Fondazione Melanoma Onlus
 2016-11-14 PHASE2
NCT05195632 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Pierre Fabre Medicament
 2022-06-02 PHASE2
NCT03231306 COMPLETED
Neurofibromatosis Type 1; Plexiform Neurofibroma
University of Alabama at Birmingham
 2017-11-28 PHASE2
NCT04543188 TERMINATED
Malignant Melanoma; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms, Primary; Brain Neoplasms; Malignant Neoplasms
Pfizer
 2021-01-08 PHASE1
NCT06207656 Not yet recruiting
Colorectal Cancer
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)|Merck S.L. Spain|Pierre Fabre Ibérica S.A.
 2024-01-19 Phase 2
NCT04720976 COMPLETED
Solid Tumor; NSCLC
Allist Pharmaceuticals, Inc.
 2021-03-23 PHASE1; PHASE2
NCT04494958 COMPLETED
Triple Negative Breast Cancer
Fundacion Oncosur
 2020-11-18 PHASE1; PHASE2
NCT04390243 TERMINATED
Locally Advanced Pancreatic Carcinoma; Metastatic Pancreatic Carcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
Academic and Community Cancer Research United
 2020-11-16 PHASE2
NCT03235245 ACTIVE_NOT_RECRUITING
Unresectable Stage III Melanoma; Stage IV Melanoma
European Organisation for Research and Treatment of Cancer - EORTC
 2018-10-30 PHASE2
NCT03843775 COMPLETED
Advanced BRAF Mutant Cancers
Memorial Sloan Kettering Cancer Center
 2019-02-14 PHASE1; PHASE2
NCT05097378 UNKNOWN
Melanoma; Cancer
CCTU- Cancer Theme
 2022-01-01 PHASE2
NCT04965818 TERMINATED
Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations; Non-Small Cell Lung Cancer; KRAS Gene Mutation
Taiho Oncology, Inc.
 2021-09-20 PHASE1
NCT04585815 TERMINATED
Carcinoma, Non-Small-Cell Lung
Pfizer
 2020-11-10 PHASE1; PHASE2
NCT04759846 WITHDRAWN
BRAF V600 Mutation; Unresectable Melanoma; Metastatic Melanoma; Hepatic Impairment
Pierre Fabre Medicament
 2021-01-21 PHASE1
NCT05286788 Recruiting
Adamantinous Craniopharyngioma|Recurrent Adamantinomatous Craniopharyngioma
Nationwide Children''s Hospital|Children''s Hospital Colorado
 2023-04-10 Phase 2
NCT02834364 COMPLETED
Relapsed or Refractory Multiple Myeloma; Patients With BRAFV600 E or BRAFV600K Mutation
University of Heidelberg Medical Center
 2016-06 PHASE2
NCT01543698 COMPLETED
Solid Tumors Harboring a BRAF V600 Mutation
Pfizer
 2012-05-28 PHASE1; PHASE2
NCT03170206 COMPLETED
Lung Cancer
Dana-Farber Cancer Institute
 2017-05-31 PHASE1
NCT02159066 COMPLETED
Melanoma
Pfizer
 2014-07-23 PHASE2
NCT04801966 TERMINATED
Cancer
Peter MacCallum Cancer Centre, Australia
 2021-09-23
NCT05810740 COMPLETED
Melanoma; BRAF V600 Mutation; Unresectable Melanoma; Metastatic Melanoma
Pierre Fabre Medicament
 2022-08-31 PHASE1
NCT04292119 UNKNOWN
Lung Cancer; Anaplastic Lymphoma Kinase Gene Translocation; ROS1 Rearrangement; Relapsed Cancer; MET Amplification; Resistant Cancer; NSCLC
Massachusetts General Hospital
 2020-05-01 PHASE1; PHASE2
NCT02613650 COMPLETED
Advanced KRAS Positive Metastatic Colorectal Cancer
University of Utah
 2016-08-19 PHASE1
NCT02285439 COMPLETED
Low-Grade Gliomas; Malignant Neoplasms, Brain; Soft Tissue Neoplasms
Children's Hospital Los Angeles
 2016-05-04 PHASE1; PHASE2
NCT03898908 COMPLETED
Metastatic Melanoma; Brain Metastases
Grupo Español Multidisciplinar de Melanoma
 2019-07-18 PHASE2
NCT04005144 TERMINATED
ALK Gene Rearrangement; Lung Non-Small Cell Carcinoma; Progressive Disease; ROS1 Gene Rearrangement; Stage IIIB Lung Cancer; Stage IIIC Lung Cancer; Stage IV Lung Cancer; Stage IVA Lung Cancer; Stage IVB Lung Cancer
University of California, San Francisco
 2020-02-25 PHASE1
NCT03915951 COMPLETED
Non-small Cell Lung Cancer
Pfizer
 2019-06-04 PHASE2
NCT04735068 COMPLETED
Non-Small Cell Lung Cancer; KRAS Mutation-Related Tumors
Abramson Cancer Center at Penn Medicine
 2021-04-09 PHASE2
NCT03878719 TERMINATED
Melanoma
Pfizer
 2020-08-03 PHASE1
NCT04655157 TERMINATED
Melanoma
Jason J. Luke, MD
 2021-05-28 PHASE1; PHASE2
NCT05810740 Completed
Melanoma|BRAF V600 Mutation|Unresectable Melanoma|Metastatic Melanoma
Pierre Fabre Medicament|Biotrial
 2022-08-31 Phase 1
NCT04044430 TERMINATED
Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Microsatellite Stable Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Stage III Colon Cancer; Stage III Colorectal Cancer; Stage III Rectal Cancer; Stage IIIA Colon Cancer; Stage IIIA Colorectal Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Colorectal Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Colorectal Cancer; Stage IIIC Rectal Cancer; Stage IV Colon Cancer; Stage IV Colorectal Cancer; Stage IV Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Colorectal Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Colorectal Cancer; Stage IVB Rectal Cancer; Stage IVC Colon Cancer; Stage IVC Colorectal Cancer; Stage IVC Rectal Cancer
University of California, San Francisco
 2020-08-31 PHASE1
NCT03864042 COMPLETED
Advanced Solid Tumors; Metastatic Melanoma
Pfizer
 2018-01-02 PHASE1
NCT05195632 Active not recruiting
Non-Small Cell Lung Cancer
Pierre Fabre Medicament
 2022-06-02 Phase 2
NCT03106415 COMPLETED
Breast Adenocarcinoma; Metastatic Triple-Negative Breast Carcinoma; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7
Mayo Clinic
 2017-09-27 PHASE1; PHASE2
NCT03973918 TERMINATED
High Grade Glioma; BRAF V600E; BRAF V600K; Anaplastic Astrocytoma; Anaplastic Pleomorphic Xanthoastrocytoma; Gliosarcoma; Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2019-07-29 PHASE2
NCT03475004 COMPLETED
Colorectal Cancer; Metastatic Cancer
University of Colorado, Denver
 2018-09-17 PHASE2
NCT03911869 TERMINATED
Brain Metastases
Pfizer
 2019-04-30 PHASE2
NCT05767879 Recruiting
Melanoma Stage III|In-Transit Metastasis of Cutaneous Melanoma
Leiden University Medical Center|Pierre Fabre Laboratories
 2022-01-01 Phase 2
NCT05103891 UNKNOWN
Melanoma; BRAF V600 Mutation; Unresectable Melanoma; Metastatic Melanoma
Pierre Fabre Medicament
 2021-09-03 PHASE1
NCT03374254 COMPLETED
Metastatic Colorectal Cancer
Merck Sharp & Dohme LLC
 2018-02-16 PHASE1
NCT03981614 COMPLETED
Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Unresectable Carcinoma
Academic and Community Cancer Research United
 2019-10-29 PHASE2
NCT02964689 COMPLETED
Advanced Non-small Cell Lung Cancer; KRAS Gene Mutation; Lung Cancer
Swiss Cancer Institute
 2017-04-12 PHASE1
NCT03158103 COMPLETED
Gastrointestinal Stromal Tumor (GIST)
Memorial Sloan Kettering Cancer Center
 2017-04-15 PHASE1
NCT03637491 TERMINATED
Pancreatic Cancer
Pfizer
 2018-08-15 PHASE1; PHASE2
NCT02902042 COMPLETED
Malignant Melanoma
Prof. Dr. med. Dirk Schadendorf
 2018-04-24 PHASE1; PHASE2
NCT03271047 COMPLETED
MSS; RAS-mutant Colorectal Cancer
Pfizer
 2017-10-18 PHASE2
NCT03693170 COMPLETED
BRAF V600E-mutant Metastatic Colorectal Cancer
Pierre Fabre Medicament
 2019-01-17 PHASE2
NCT02263898 WITHDRAWN
Recurrent Melanoma; Stage IV Melanoma
Jonsson Comprehensive Cancer Center
 2015-01 PHASE2
NCT02276027 COMPLETED
Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma
Novartis Pharmaceuticals
 2015-01-20 PHASE2
NCT01859026 COMPLETED
Lung Cancer; Non-Small Cell Lung Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2013-12-30 PHASE1
NCT02185690 COMPLETED
Lungcancer
University Health Network, Toronto
 2017-03-07 PHASE1
NCT02089230 TERMINATED
Leukemia
M.D. Anderson Cancer Center
 2014-08-27 PHASE1; PHASE2
NCT01828034 COMPLETED
Advanced Biliary Tract Carcinoma
Memorial Sloan Kettering Cancer Center
 2013-04 PHASE1; PHASE2
NCT04439344 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-05-31 PHASE2
NCT02928224 COMPLETED
BRAF V600E-mutant Metastatic Colorectal Cancer
Pfizer
 2016-10-13 PHASE3
NCT02773459 COMPLETED
Biliary Tract Cancer
Seoul National University Hospital
 2016-04 PHASE1; PHASE2
NCT02510001 COMPLETED
Solid Tumor; Colorectal Cancer
University of Oxford
 2014-11 PHASE1
NCT02094872 COMPLETED
Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma
Yale University
 2014-05 PHASE2
NCT02451865 WITHDRAWN
Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer
Jonsson Comprehensive Cancer Center
 2016-06 PHASE1
NCT02041481 COMPLETED
Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer
City of Hope Medical Center
 2014-06 PHASE1
NCT01781572 COMPLETED
Locally Advanced or Metastatic NRAS Mutant Melanoma
Pfizer
 2013-06 PHASE1; PHASE2
NCT01556568 WITHDRAWN
Cardiomegaly
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2012-02 PHASE2
NCT02225574 TERMINATED
Leukemia
M.D. Anderson Cancer Center
 2015-03-11 PHASE1
NCT01909453 COMPLETED
Melanoma
Pfizer
 2013-09-12 PHASE3
NCT01449058 COMPLETED
Advanced and Selected Solid Tumors; AML; High Risk and Very High Risk MDS
Array BioPharma
 2012-03 PHASE1
NCT02050815 TERMINATED
Hepatic Impairment
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2014-03 PHASE1
NCT01649336 COMPLETED
Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2012-07 PHASE1
NCT01927341 COMPLETED
Metastatic Colorectal Cancer
Pfizer
 2013-11-19 PHASE1; PHASE2
NCT01849874 TERMINATED
Low-grade Serous Ovarian Cancer; Low-grade Serous Fallopian Tube Cancer; Low-grade Serous Peritoneal Cancer
Pfizer
 2013-06-27 PHASE3
NCT01763164 COMPLETED
Metastatic or Unresectable Cutaneous Melanoma
Pfizer
 2013-07-12 PHASE3
NCT01885195 COMPLETED
Solid Tumor and Hematologic Malignancies
Pfizer
 2013-10-10 PHASE2
NCT02105350 WITHDRAWN
Biliary Tract Carcinoma; Gallbladder Carcinoma
University Health Network, Toronto
 2015-06 PHASE1
NCT01801358 TERMINATED
Uveal Melanoma
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2013-08 PHASE1; PHASE2
NCT01562899 TERMINATED
Metastatic Pancreatic Adenocarcinoma; BRAF Mutated Melanoma
Pfizer
 2012-08-27 PHASE1; PHASE2
NCT02049801 TERMINATED
Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
Bruno C. Medeiros
 2014-12 PHASE1
NCT01469130 COMPLETED
Advanced Solid Tumor
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2011-11 PHASE1
NCT01363232 COMPLETED
Advanced Solid Tumors; Selected Solid Tumors
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2011-08 PHASE1
NCT01320085 COMPLETED
BRAF or NRAS Mutant Metastatic Melanoma
Pfizer
 2011-03-24 PHASE2
NCT01352273 COMPLETED
Advanced Solid Tumors
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2011-06 PHASE1
NCT01337765 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific; Solid Tumor
Pfizer
 2011-07-08 PHASE1
NCT00959127 COMPLETED
Advanced Solid Tumors; Advanced or Metastatic Biliary Cancer; Metastatic Colorectal Cancer
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2009-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the MEK162 (Binimetinib, ARRY-162) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Binimetinib selectively binds to and inhibits MEK1 and MEK2 with an IC50 of 12 nM, thereby preventing downstream phosphorylation and activation of the MAPK signaling cascade. This molecular blockade triggers G1 phase cell cycle arrest, apoptosis, and autophagy in target cells, suppressing tumor growth in clinical conditions such as BRAF-mutated melanoma and non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.