Clinical Trials

Numerous clinical trials evaluate selumetinib across diverse oncology and genetic indications, notably neurofibromatosis type 1—including plexiform neurofibromas, cutaneous neurofibromas, and optic nerve gliomas—as well as papillary thyroid carcinoma, biliary tract carcinoma, sarcomas, and advanced solid tumors. Spanning Early Phase 1 through Phase 3, these studies encompass actively recruiting, completed, and market-approved trials. Investigations are broadly supported by industry sponsors, including AstraZeneca and Merck Sharp & Dohme, alongside major public institutions such as the National Cancer Institute and the United States Department of Defense.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07713745 NOT_YET_RECRUITING
Neurofibromatosis Type 2; Vestibular Schwannoma; Non-vestibular Schwannoma; Meningioma; Ependymoma; NF2-related Schwannomatosis; NF2
Beijing Tiantan Hospital
2026-07-18 PHASE2
NCT06502171 RECRUITING
Neurofibromatosis 1; Plexiform Neurofibroma
Girish Dhall, MD
2026-06-09 PHASE1
NCT05253131 RECRUITING
MPNST; NF1; Sarcoma
University of Alabama at Birmingham
2026-08-04 PHASE2
NCT06188741 RECRUITING
Neurofibromatosis 1; Plexiform Neurofibroma
University of Alabama at Birmingham
2025-08-27 PHASE2
NCT02813135 RECRUITING
Pediatric Cancer
Gustave Roussy, Cancer Campus, Grand Paris
2016-08-03 PHASE1; PHASE2
NCT04166409 RECRUITING
Low Grade Astrocytoma; Low Grade Glioma; Metastatic Low Grade Astrocytoma; Metastatic Low Grade Glioma; WHO Grade 1 Glioma; WHO Grade 2 Glioma
National Cancer Institute (NCI)
2020-01-31 PHASE3
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
NCT07707947 NOT_YET_RECRUITING
Neurofibromatosis Type 2; NF2; NF2-related Schwannomatosis; Meningioma; Ependymoma; Vestibular Schwannoma
Beijing Tiantan Hospital
2026-07-15 PHASE2
NCT05554328 ACTIVE_NOT_RECRUITING
Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
National Cancer Institute (NCI)
2023-04-25 PHASE2
NCT06763315 NOT_YET_RECRUITING
Plexiform Neurofibromas (PN)
West China Hospital
2025-01-01 PHASE2
NCT02407405 ACTIVE_NOT_RECRUITING
Neurofibromatosis 1 (NF1); Plexiform Neurofibromas (PN)
National Cancer Institute (NCI)
2016-01-07 PHASE2
NCT03871257 ACTIVE_NOT_RECRUITING
Low Grade Glioma; Neurofibromatosis Type 1; Visual Pathway Glioma
National Cancer Institute (NCI)
2020-01-15 PHASE3
NCT05309668 ACTIVE_NOT_RECRUITING
Neurofibromatosis Type 1
AstraZeneca
2022-01-21 PHASE1; PHASE2
NCT06735820 RECRUITING
Malignant Peripheral Nerve Sheath Tumor (MPNST); Neurofibromatosis 1 (NF1); Atypical Neurofibroma
AeRang Kim
2026-06-01 PHASE1; PHASE2
NCT03326310 RECRUITING
Chronic Myeloid Leukemia; Myelofibroses
University of Chicago
2018-09-04 PHASE1
NCT03392246 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Dana-Farber Cancer Institute
2018-01-31 PHASE2
NCT02151084 ACTIVE_NOT_RECRUITING
Biliary Tract Carcinoma; Gallbladder Carcinoma
University Health Network, Toronto
2014-11 PHASE2
NCT01362803 ACTIVE_NOT_RECRUITING
Neurofibromatosis 1; Neurofibromatosis Type 1; NF1; Neurofibroma, Plexiform
National Cancer Institute (NCI)
2011-09-21 PHASE1; PHASE2
NCT04576117 ACTIVE_NOT_RECRUITING
Recurrent Low Grade Astrocytoma; Recurrent WHO Grade 2 Glioma; Refractory Low Grade Astrocytoma; Refractory Low Grade Glioma; Refractory WHO Grade 1 Glioma
National Cancer Institute (NCI)
2021-02-16 PHASE3
NCT06621082 NOT_YET_RECRUITING
Neurofibromatosis 1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2024-09-30 PHASE2
NCT06620354 NOT_YET_RECRUITING
Neurofibromatosis 1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2024-09-30 PHASE2
NCT07619521 NOT_YET_RECRUITING
Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma
National Cancer Institute (NCI)
2026-09-08 PHASE1; PHASE2
NCT03162627 ACTIVE_NOT_RECRUITING
Malignant Neoplasm of Breast; Malignant Neoplasms of Digestive Organs; Malignant Neoplasms of Female Genital Organs; Malignant Neoplasms of Male Genital Organs; Malignant Neoplasms of Thyroid and Other Endocrine Glands
M.D. Anderson Cancer Center
2017-08-04 PHASE1
NCT05825365 WITHDRAWN
Neurofibromatosis Type 1; Plexiform Neurofibromas; Post-operative
AstraZeneca
2023-08-31 PHASE2
NCT01089101 ACTIVE_NOT_RECRUITING
Low Grade Glioma; Recurrent Childhood Pilocytic Astrocytoma; Recurrent Neurofibromatosis Type 1; Recurrent Visual Pathway Glioma; Refractory Neurofibromatosis Type 1; Refractory Visual Pathway Glioma
National Cancer Institute (NCI)
2010-07-07 PHASE1; PHASE2
NCT03581487 COMPLETED
Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
M.D. Anderson Cancer Center
2019-04-01 PHASE1; PHASE2
NCT03944772 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
AstraZeneca
2019-06-25 PHASE2
NCT03155620 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor
National Cancer Institute (NCI)
2017-07-31 PHASE2
NCT03801369 TERMINATED
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma
Gordon Mills, MD, PhD
2018-12-12 PHASE2
NCT04924608 ACTIVE_NOT_RECRUITING
Neurofibromatosis 1; Plexiform Neurofibroma (PN)
AstraZeneca
2021-11-19 PHASE3
NCT05253131 Not yet recruiting
MPNST|NF1|Sarcoma
University of Alabama at Birmingham|United States Department of Defense
2024-06-15 Phase 2
NCT03095248 TERMINATED
Neurofibromatosis 2; Vestibular Schwannoma; Meningioma; Ependymoma; Glioma
Children's Hospital Medical Center, Cincinnati
2017-05-08 PHASE2
NCT03326388 COMPLETED
Neurofibromatosis Type 1; Plexiform Neurofibroma; Optic Nerve Glioma
Great Ormond Street Hospital for Children NHS Foundation Trust
2019-09-26 PHASE1; PHASE2
NCT06175637 Recruiting
Neurofibroma Plexiform
AstraZeneca
2023-12-20 --
NCT02664935 COMPLETED
Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma
University of Birmingham
2015-05-13 PHASE2
NCT04348045 ACTIVE_NOT_RECRUITING
Metastatic Pancreatic Adenocarcinoma
GERCOR - Multidisciplinary Oncology Cooperative Group
2020-12-07 PHASE2
NCT03705507 TERMINATED
Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia, Adult; Acute Lymphoblastic Leukemia, Pediatric; Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia Recurrent
University of Birmingham
2018-05-18 PHASE1; PHASE2
NCT03004105 WITHDRAWN
Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma; Advanced Lung Cancer; Recurrent Nonsmall Cell Lung Cancer
M.D. Anderson Cancer Center
2018-05 PHASE2
NCT05891847 Recruiting
Neurofibroma
AstraZeneca
2023-03-21 --
NCT02299999 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
UNICANCER
2014-04-07 PHASE2
NCT02839720 COMPLETED
Cutaneous Neurofibroma; Neurofibromatosis Type 1; Optic Nerve Glioma
National Cancer Institute (NCI)
2017-08-26 PHASE2
NCT04590235 ACTIVE_NOT_RECRUITING
Neurofibromatosis 1; Neurofibroma Plexiform
AstraZeneca
2020-12-16 PHASE1
NCT03833427 TERMINATED
Advanced/Metastatic Solid Tumors
Merck Sharp & Dohme LLC
2019-03-18 PHASE1
NCT03433183 COMPLETED
Malignant Peripheral Nerve Sheath Tumors; Neurofibromatosis 1
Sarcoma Alliance for Research through Collaboration
2019-10-02 PHASE2
NCT05101148 ACTIVE_NOT_RECRUITING
Neurofibromatosis Type 1
AstraZeneca
2021-07-21 PHASE1
NCT05101148 Active not recruiting
Neurofibromatosis Type 1
AstraZeneca|Merck Sharp & Dohme LLC
2021-07-21 Phase 1
NCT03213691 COMPLETED
Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma; Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma; Recurrent Childhood Central Nervous System Neoplasm; Recurrent Childhood Non-Hodgkin Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Neuroblastoma; Refractory Malignant Solid Neoplasm; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Central Nervous System Neoplasm
National Cancer Institute (NCI)
2017-10-30 PHASE2
NCT04495127 COMPLETED
Neurofibromatosis Type 1
AstraZeneca
2020-08-31 PHASE1
NCT04879160 Completed
Neurofibromatosis 1
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
2021-05-12 --
NCT03745989 COMPLETED
Solid Tumors
Merck Sharp & Dohme LLC
2019-02-22 PHASE1
NCT01248247 COMPLETED
Lung Cancer
M.D. Anderson Cancer Center
2011-06-02 PHASE2
NCT02768766 COMPLETED
Uveal Melanoma
Shaheer A. Khan
2017-02-28 PHASE1
NCT02393690 COMPLETED
Metastatic Thyroid Gland Carcinoma; Poorly Differentiated Thyroid Gland Carcinoma; Recurrent Thyroid Gland Carcinoma; Stage IV Thyroid Gland Follicular Carcinoma AJCC v7; Stage IV Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7
Academic and Community Cancer Research United
2015-05-04 PHASE2
NCT02503358 COMPLETED
Stage IIIB Non-Small Cell Lung Cancer AJCC v7; Stage IV Non-Small Cell Lung Cancer AJCC v7
OHSU Knight Cancer Institute
2016-07-21 PHASE1
NCT01586624 COMPLETED
Cancer; Non Small Cell Lung Cancer
Cancer Research UK
2012-01-10 PHASE1
NCT02546661 ACTIVE_NOT_RECRUITING
Muscle Invasive Bladder Cancer
AstraZeneca
2016-12-28 PHASE1
NCT02143466 ACTIVE_NOT_RECRUITING
Advanced Non Small Cell Lung Cancer
AstraZeneca
2014-08-05 PHASE1
NCT02583542 UNKNOWN
Triple-Negative Breast Cancer; Squamous Cell Lung Cancer; Non-squamous Cell Lung Cancer With KRAS Mutations; Non-squamous Cell Lung Cancer With Wild-type KRAS
Queen Mary University of London
2015-06 PHASE1; PHASE2
NCT01364051 ACTIVE_NOT_RECRUITING
Metastatic Melanoma; Refractory Malignant Solid Neoplasm; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
2011-05-25 PHASE1
NCT02450656 UNKNOWN
Colorectal Neoplasms; Gastrointestinal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung
The Netherlands Cancer Institute
2015-06 PHASE1; PHASE2
NCT03109301 WITHDRAWN
Neoplasms, Nerve Tissue; Neurofibromatosis 1; Heredodegenerative Disorders, Nervous System; Peripheral Nervous System Diseases
National Cancer Institute (NCI)
2017-04-07 PHASE2
NCT02117167 COMPLETED
Non-small Cell Lung Cancer Metastatic
UNICANCER
2014-04-23 PHASE2
NCT03649165 COMPLETED
Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs); Healthy Participants
AstraZeneca
2018-09-05 PHASE1
NCT03040986 COMPLETED
KRAS NP_004976.2:p.G12R; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IV Pancreatic Cancer AJCC v6 and v7
National Cancer Institute (NCI)
2017-07-21 PHASE2
NCT02586987 COMPLETED
Lung Cancer; Melanoma; Head and Neck Carcinoma; Gastroesophageal Cancer; Breast Cancer; Pancreatic Adenocarcinoma; Colorectal Cancer; Biliary Tract Cancer
AstraZeneca
2015-12-28 PHASE1
NCT01843062 TERMINATED
Differentiated Thyroid Cancer
AstraZeneca
2013-08-27 PHASE3
NCT02448290 COMPLETED
Gastric Adenocarcinoma
Samsung Medical Center
2014-11-12 PHASE2
NCT02025114 COMPLETED
Non-small Cell Lung Cancer (NSCLC)
National Taiwan University Hospital
2014-09 PHASE1; PHASE2
NCT02685657 UNKNOWN
Triple Negative Breast Cancer
Russian Academy of Medical Sciences
2016-09 PHASE2
NCT02337530 COMPLETED
Non-Small Cell Lung Cancer
Canadian Cancer Trials Group
2015-05-26 PHASE2
NCT01783197 COMPLETED
Non Small Cell Lung Cancer
Canadian Cancer Trials Group
2013-06-04 PHASE1
NCT01146756 COMPLETED
Non Small Cell Lung Cancer
The Christie NHS Foundation Trust
2010-06-04 PHASE1
NCT02188264 COMPLETED
Recurrent Colorectal Carcinoma; Solid Neoplasm; Stage IIIA Colorectal Cancer AJCC v7; Stage IIIB Colorectal Cancer AJCC v7; Stage IIIC Colorectal Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7
National Cancer Institute (NCI)
2014-08-29 PHASE1
NCT00559949 COMPLETED
Recurrent Thyroid Gland Carcinoma; Stage I Thyroid Gland Papillary Carcinoma; Stage II Thyroid Gland Papillary Carcinoma; Stage III Thyroid Gland Papillary Carcinoma; Stage IV Thyroid Gland Papillary Carcinoma
National Cancer Institute (NCI)
2007-12 PHASE2
NCT02179671 COMPLETED
Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
AstraZeneca
2014-07-25 PHASE2
NCT01933932 ACTIVE_NOT_RECRUITING
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
AstraZeneca
2013-09-25 PHASE3
NCT01143402 COMPLETED
Iris Melanoma; Medium/Large Size Posterior Uveal Melanoma; Ocular Melanoma With Extraocular Extension; Recurrent Uveal Melanoma; Small Size Posterior Uveal Melanoma; Stage IV Uveal Melanoma
National Cancer Institute (NCI)
2010-06 PHASE2
NCT01750281 COMPLETED
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
AstraZeneca
2012-12-18 PHASE2
NCT01809210 COMPLETED
Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV
AstraZeneca
2013-04-04 PHASE1
NCT01011933 COMPLETED
Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Recurrent Uterine Corpus Carcinoma
National Cancer Institute (NCI)
2009-09 PHASE2
NCT01752569 TERMINATED
AIDS-related Kaposi's Sarcoma
Sheffield Teaching Hospitals NHS Foundation Trust
2012-06-15 PHASE1; PHASE2
NCT01658943 COMPLETED
Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer
National Cancer Institute (NCI)
2012-08 PHASE2
NCT01974752 COMPLETED
Metastatic; Uveal Melanoma
AstraZeneca
2014-04 PHASE3
NCT01605916 COMPLETED
Neoplasms,; Metastatic Cancer,; Non-Small Cell Lung Cancer; Advanced Solid Malignancies
AstraZeneca
2012-06 PHASE1
NCT01206140 COMPLETED
Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
National Cancer Institute (NCI)
2010-10 PHASE2
NCT02322749 COMPLETED
Healthy Volunteers Bioequivalence or Bioavailability Study
AstraZeneca
2015-02 PHASE1
NCT00888134 COMPLETED
Adult Solid Neoplasm
National Cancer Institute (NCI)
2009-07 PHASE2
NCT02238782 COMPLETED
Healthy Volunteers Bioavailability Study
AstraZeneca
2014-10 PHASE1
NCT02063230 COMPLETED
Solid Tumors
AstraZeneca
2014-03 PHASE1
NCT02056392 COMPLETED
Solid Tumours
AstraZeneca
2014-03 PHASE1
NCT01949870 TERMINATED
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
AstraZeneca
2013-10 PHASE1
NCT02063204 COMPLETED
Solid Tumours
AstraZeneca
2014-03 PHASE1
NCT02093728 COMPLETED
Solid Tumours
AstraZeneca
2014-04 PHASE1
NCT01960374 COMPLETED
Healthy Volunteers Pharmacokinetic Study
AstraZeneca
2013-10 PHASE1
NCT00780676 TERMINATED
Breast Cancer
M.D. Anderson Cancer Center
2009-06 PHASE2
NCT02046850 COMPLETED
Solid Tumours
AstraZeneca
2014-02 PHASE1
NCT01313039 COMPLETED
Breast Cancer
University of Miami
2011-02 EARLY_PHASE1
NCT01306045 COMPLETED
Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell Lung; Carcinoma, Thymic
National Cancer Institute (NCI)
2011-02-08 PHASE2
NCT01974349 COMPLETED
Solid Tumours
AstraZeneca
2013-11 PHASE1
NCT01278615 TERMINATED
Recurrent Adult Diffuse Large Cell Lymphoma
National Cancer Institute (NCI)
2010-12 PHASE2
NCT01029418 TERMINATED
Hepatocellular Carcinoma
National Cancer Centre, Singapore
2009-11 PHASE1; PHASE2
NCT01931761 COMPLETED
Solid Tumours
AstraZeneca
2013-10 PHASE1
NCT01333475 COMPLETED
Colorectal Neoplasms
National Cancer Institute (NCI)
2011-03 PHASE2
NCT01160926 TERMINATED
Rectal Cancer
The Christie NHS Foundation Trust
2010-07 PHASE1
NCT01229150 COMPLETED
Non Small Cell Lung Carcinoma
National Cancer Institute (NCI)
2010-10-26 PHASE2
NCT00866177 COMPLETED
Recurrent Melanoma; Stage III Skin Melanoma; Stage IV Skin Melanoma
National Cancer Institute (NCI)
2009-03 PHASE2
NCT01287130 COMPLETED
Colonic Neoplasms; Cancer of the Colon; Colon Cancer; Colon Neoplasms; Colonic Cancer
National Cancer Institute (NCI)
2011-01-07 PHASE1
NCT00551070 COMPLETED
Borderline Ovarian Serous Tumor; Low Grade Ovarian Serous Adenocarcinoma; Micropapillary Serous Carcinoma; Primary Peritoneal Carcinoma; Primary Peritoneal Low Grade Serous Adenocarcinoma; Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor
National Cancer Institute (NCI)
2007-12-17 PHASE2
NCT01859182 WITHDRAWN
Adenocarcinoma of the Gallbladder; Adenocarcinoma With Squamous Metaplasia of the Gallbladder; Adult Primary Cholangiocellular Carcinoma; Advanced Adult Primary Liver Cancer; Cholangiocarcinoma of the Extrahepatic Bile Duct; Localized Unresectable Adult Primary Liver Cancer; Metastatic Extrahepatic Bile Duct Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Stage II Gallbladder Cancer; Stage IIIA Gallbladder Cancer; Stage IIIB Gallbladder Cancer; Stage IVA Gallbladder Cancer; Stage IVB Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer
National Cancer Institute (NCI)
2013-01 PHASE2
NCT01519427 TERMINATED
Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2012-01 PHASE2
NCT01222689 COMPLETED
Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer
National Cancer Institute (NCI)
2010-11 PHASE2
NCT01061749 COMPLETED
Adult Solid Neoplasm
National Cancer Institute (NCI)
2009-11 PHASE1
NCT00970359 COMPLETED
Thyroid Cancer
Memorial Sloan Kettering Cancer Center
2009-09
NCT01242605 COMPLETED
Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms
University College, London
2012-02 PHASE1
NCT00553332 COMPLETED
Liver and Intrahepatic Biliary Tract Cancer; Recurrent Extrahepatic Bile Duct Cancer; Unresectable Extrahepatic Bile Duct Cancer
National Cancer Institute (NCI)
2007-11 PHASE2
NCT01160718 COMPLETED
Breast Cancer
Swiss Cancer Institute
2010-08 PHASE2
NCT01217450 COMPLETED
Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2012-10 PHASE1
NCT01021748 COMPLETED
Locally Advanced or Metastatic Solid Tumors
Merck Sharp & Dohme LLC
2009-11-23 PHASE1
NCT01134601 TERMINATED
Non-Metastatic Adenocarcinoma of the Rectum
National Cancer Institute (NCI)
2010-05-24 PHASE1
NCT01256359 COMPLETED
Melanoma
University of Oxford
2010-10 PHASE2
NCT01635023 COMPLETED
Healthy Volunteers
AstraZeneca
2012-07 PHASE1
NCT01116271 COMPLETED
Colorectal Cancer
AstraZeneca
2010-04 PHASE2
NCT00604721 COMPLETED
Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer
National Cancer Institute (NCI)
2007-11 PHASE2
NCT01166126 TERMINATED
Mucosal Melanoma; Recurrent Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2010-10 PHASE2
NCT00588809 COMPLETED
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Promyelocytic Leukemia (M3); Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia
National Cancer Institute (NCI)
2007-12 PHASE2
NCT01085214 COMPLETED
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
National Cancer Institute (NCI)
2010-03 PHASE2
NCT00936221 COMPLETED
Melanoma
AstraZeneca
2009-07 PHASE2
NCT00890825 COMPLETED
Non Small Cell Lung Cancer
AstraZeneca
2009-04-20 PHASE2
NCT00600496 COMPLETED
Breast Cancer; Breast Neoplasms; Colon Cancer; Colonic Cancer; Colon Neoplasms; Lung Cancer; Melanoma; Kidney Cancer
AstraZeneca
2007-12-14 PHASE1
NCT00710515 COMPLETED
Melanoma; Malignant Melanoma
AstraZeneca
2008-07 PHASE1
NCT00463814 ACTIVE_NOT_RECRUITING
Tumor; Cancer
AstraZeneca
2007-03-08 PHASE1
NCT00372944 COMPLETED
Pancreatic Cancer
AstraZeneca
2006-08 PHASE2
NCT00338130 COMPLETED
Melanoma
AstraZeneca
2006-07 PHASE2
NCT00372788 COMPLETED
Non-small Cell Lung Cancer
AstraZeneca
2006-08 PHASE2
NCT00514761 COMPLETED
Metastatic Colorectal Cancer
AstraZeneca
2006-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-20)

Check the AZD6244 (Selumetinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Selumetinib (AZD6244) potently and selectively binds to mitogen-activated protein kinase kinase 1 (MEK1) and MEK2, inhibiting catalytic activity and preventing downstream phosphorylation of extracellular signal-regulated kinases 1 and 2 (ERK1/2) within the MAPK signaling pathway. This biochemical inhibition suppresses cellular proliferation, impairs migration, and triggers apoptosis, translating clinically to tumor regression and disease stabilization in RAS-RAF-driven pathologies such as neurofibromatosis type 1-associated plexiform neurofibromas and papillary thyroid carcinoma.

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>).

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