Clinical Trials

Numerous clinical trials evaluate dabrafenib across Phase 1 through Phase 4 studies for indications including BRAF V600 mutation-positive melanoma, anaplastic thyroid cancer, non-small-cell lung cancer, and differentiated thyroid cancer. Investigating dabrafenib both as a single agent and in combined targeted regimens, these evaluations are sponsored by pharmaceutical organizations and academic medical centers. Trial recruitment statuses range from active and recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06119789 RECRUITING
Rare Malignant Neoplasm
Oslo University Hospital
 2025-03-20 PHASE2
NCT03340506 RECRUITING
Melanoma; Non Small Cell Lung Cancer; Solid Tumor; Rare Cancers; High Grade Glioma
Novartis Pharmaceuticals
 2018-01-26 PHASE4
NCT07110246 RECRUITING
BRAF V600 Mutation; Low-grade Glioma; Low Grade Glioma of Brain; Recurrent Low Grade Glioma
University of California, San Francisco
 2025-11-07 PHASE2
NCT06475989 RECRUITING
Refractory Differentiated Thyroid Gland Carcinoma
ECOG-ACRIN Cancer Research Group
 2024-08-22 PHASE3
NCT05722886 RECRUITING
Haematological Malignancy; Solid Tumour
Cancer Research UK
 2023-03-01 PHASE2; PHASE3
NCT07440290 RECRUITING
Haematological Malignancy; Malignant Neoplasm; Lymphoproliferative Disorders; Neoplasms by Histologic Type; Neoplasms by Site; Gastrointestinal Cancer; Non-Melanoma Skin Cancer (NMSC); Langerhans Cell Histiocytosis (LCH); Cancer; Erdheim-Chester Disease; Thyroid Carcinoma, Papillary; Ovarian Neoplasms; Colorectal Neoplasms; Laryngeal Neoplasms; Carcinoma, Non-Small Cell-Lung; Glioma; Multiple Myeloma; Thyroid Carcinoma, Anaplastic; Solid Tumour; Pancreatic Diseases
Cancer Research UK
 2026-04-01 PHASE2; PHASE3
NCT06712875 RECRUITING
Low Grade Glioma; High Grade Glioma
Ann & Robert H Lurie Children's Hospital of Chicago
 2025-04-01 PHASE1; PHASE2
NCT06819605 NOT_YET_RECRUITING
Ameloblastoma
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
 2025-03-01 PHASE2; PHASE3
NCT04903119 RECRUITING
Metastatic Melanoma; BRAF Gene Mutation
Rina Plattner
 2022-06-01 PHASE1
NCT07022834 RECRUITING
Langerhans Cell Histiocytosis (LCH)
West China Second University Hospital
 2025-06-01 PHASE2
NCT02693535 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
American Society of Clinical Oncology
 2016-03-14 PHASE2
NCT07010393 NOT_YET_RECRUITING
Thyroid Neoplasms
Fujian Medical University
 2025-07-01 PHASE4
NCT01989585 ACTIVE_NOT_RECRUITING
Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Malignant Solid Neoplasm; Metastatic Melanoma; Unresectable Melanoma
National Cancer Institute (NCI)
 2014-03-24 PHASE1; 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
NCT07506109 RECRUITING
BRAF V600E; Colorectal Cancer; Sintilimab; MSS (Microsatellite Stable); Cetuximab; Dabrafenib; Ipilimumab N01
Tianjin Medical University Cancer Institute and Hospital
 2026-03-01 PHASE2
NCT06978400 RECRUITING
Neoplasms
Blokhin's Russian Cancer Research Center
 2025-03-01 PHASE2
NCT06967155 ACTIVE_NOT_RECRUITING
Neoplasms
Blokhin's Russian Cancer Research Center
 2025-03-01 PHASE2
NCT06563999 RECRUITING
Lung Cancer Stage III; Mutation
Sun Yat-sen University
 2024-11-01 PHASE2
NCT03975231 RECRUITING
BRAF NP_004324.2:p.V600E; BRAF V600K Mutation Present; Thyroid Gland Anaplastic Carcinoma
City of Hope Medical Center
 2020-09-14 PHASE1
NCT03919071 ACTIVE_NOT_RECRUITING
Anaplastic Astrocytoma; Anaplastic Astrocytoma, Not Otherwise Specified; Anaplastic Ganglioglioma; Anaplastic Pleomorphic Xanthoastrocytoma; Glioblastoma; Malignant Glioma; WHO Grade 3 Glioma; WHO Grade 4 Glioma
National Cancer Institute (NCI)
 2020-02-20 PHASE2
NCT05525273 RECRUITING
Craniopharyngioma
Eva Marie Erfurth, MD, PhD
 2023-09-01 PHASE2
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
 2016-08 PHASE2
NCT04238624 ACTIVE_NOT_RECRUITING
Anaplastic Thyroid Cancer; Thyroid Cancer; BRAF Gene Mutation; BRAF Mutation-Related Tumors
Memorial Sloan Kettering Cancer Center
 2020-01-20 PHASE2
NCT02231775 ACTIVE_NOT_RECRUITING
Stage IIIB Cutaneous Melanoma AJCC v7; Stage IIIC Cutaneous Melanoma AJCC v7
M.D. Anderson Cancer Center
 2014-10-22 PHASE2
NCT02196181 ACTIVE_NOT_RECRUITING
Stage III Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Melanoma
National Cancer Institute (NCI)
 2014-09-19 PHASE2
NCT06079333 RECRUITING
Anaplastic Thyroid Cancer
Leiden University Medical Center
 2023-01-01 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
NCT06739395 RECRUITING
Solid Tumor; Precision Medicine
Tianjin Medical University Second Hospital
 2024-11-01 PHASE2
NCT06195228 RECRUITING
Advanced Thyroid Cancer Patients Who Received Target Therapy
Fudan University
 2020-01-01 PHASE4
NCT06653517 RECRUITING
Ameloblastoma; BRAF V600E Mutation Positive
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
 2023-01-01 PHASE2
NCT05159245 RECRUITING
Advanced Cancer; Solid Tumor; Haematological Malignancy
Helsinki University Central Hospital
 2021-12-10 PHASE2
NCT03975829 ACTIVE_NOT_RECRUITING
Diffuse Astrocytoma; Anaplastic Astrocytoma; Astrocytoma; Oligodendroglioma, Childhood; Anaplastic Oligodendroglioma; Glioblastoma; Pilocytic Astrocytoma; Giant Cell Astrocytoma; Pleomorphic Xanthoastrocytoma; Anaplastic Pleomorphic Xanthoastrocytoma; Angiocentric Glioma; Chordoid Glioma of Third Ventricle; Gangliocytoma; Ganglioglioma; Anaplastic Ganglioglioma; Dysplastic Gangliocytoma of Cerebrellum; Desmoplastic Infantile Astrocytoma and Ganglioglioma; Papillary Glioneuronal Tumor; Rosette-forming Glioneuronal Tumor; Central Neurocytoma; Extraventricular Neurocytoma; Cerebellar Liponeurocytoma; Neurofibromatosis Type 1
Novartis Pharmaceuticals
 2019-11-04 PHASE4
NCT04675710 ACTIVE_NOT_RECRUITING
Thyroid Gland Anaplastic Carcinoma; Thyroid Gland Squamous Cell Carcinoma
M.D. Anderson Cancer Center
 2021-06-24 PHASE2
NCT04116541 RECRUITING
Malignant Solid Tumor
Centre Leon Berard
 2020-01-28 PHASE2
NCT04544111 ACTIVE_NOT_RECRUITING
Thyroid Cancer; Thyroid Cancer, Follicular; Papillary Thyroid Cancer; Follicular Thyroid Cancer; Hurthle Cell Tumor; Poorly Differentiated Thyroid Gland Carcinoma; Hurthle Cell Thyroid Neoplasia
Memorial Sloan Kettering Cancer Center
 2020-09-02 PHASE2
NCT03091257 ACTIVE_NOT_RECRUITING
Multiple Myeloma
Massachusetts General Hospital
 2017-06-21 PHASE1
NCT05585320 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor; Pancreatic Adenocarcinoma; Malignant Melanoma (Cutaneous); Non-small Cell Lung Cancer (NSCLC)
Immuneering Corporation
 2022-10-31 PHASE1; PHASE2
NCT01947023 ACTIVE_NOT_RECRUITING
Metastatic Thyroid Gland Carcinoma; Unresectable Thyroid Gland Carcinoma
National Cancer Institute (NCI)
 2013-09-27 PHASE1
NCT04201457 ACTIVE_NOT_RECRUITING
Low Grade Glioma (LGG) of Brain With BRAF Aberration; High Grade Glioma (HGG) of the Brain With BRAF Aberration; Low Grade Glioma of Brain With Neurofibromatosis Type 1
Pediatric Brain Tumor Consortium
 2020-01-17 PHASE1; PHASE2
NCT06362694 UNKNOWN
Anaplastic Thyroid Cancer
Saint Petersburg State University, Russia
 2024-03-25 PHASE2
NCT05876806 UNKNOWN
Cancer
Se Jun Park
 2023-06-20 PHASE2
NCT04418167 SUSPENDED
Solid Tumors
JS InnoPharm, LLC
 2020-06-18 PHASE1
NCT06264778 UNKNOWN
Ameloblastoma
Shandong University
 2024-03-01 PHASE3
NCT04557956 ACTIVE_NOT_RECRUITING
Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma
National Cancer Institute (NCI)
 2021-08-19 PHASE1; PHASE2
NCT06054191 NOT_YET_RECRUITING
NSCLC; BRAF V600 Mutation; MET Exon 14 Mutation
Sun Yat-sen University
 2024-02-01 PHASE2
NCT05963087 UNKNOWN
Advanced Colorectal Cancer
Zhejiang Cancer Hospital
 2023-08
NCT04940052 ACTIVE_NOT_RECRUITING
Differentiated Thyroid Cancer (DTC)
Novartis Pharmaceuticals
 2021-11-15 PHASE3
NCT03026517 COMPLETED
Melanoma
Memorial Sloan Kettering Cancer Center
 2017-01 PHASE1
NCT04619316 UNKNOWN
Metastatic Thyroid Cancer
University Hospital, Essen
 2018-02-05 PHASE2
NCT05182931 UNKNOWN
Thyroid Cancer
Olivia Newton-John Cancer Research Institute
 2022-07-14 PHASE2
NCT06482086 RECRUITING
Locally Advanced Thyroid Gland Carcinoma
West China Hospital
 2021-06-01 PHASE2
NCT05388877 TERMINATED
Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Neoplasm in the Central Nervous System; Metastatic Melanoma
Mayo Clinic
 2022-10-20 PHASE1
NCT04452877 COMPLETED
Carcinoma, Non-Small-Cell Lung
Novartis Pharmaceuticals
 2020-08-19 PHASE2
NCT04294160 TERMINATED
BRAF V600 Colorectal Cancer
Novartis Pharmaceuticals
 2020-07-22 PHASE1
NCT03563729 RECRUITING
Malignant Melanoma
Inge Marie Svane
 2018-06-06 PHASE2
NCT02872259 COMPLETED
Melanoma
Haukeland University Hospital
 2017-02-13 PHASE1; PHASE2
NCT04527549 TERMINATED
Clinical Stage IV Cutaneous Melanoma AJCC v8; Locally Advanced Melanoma; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Unresectable Melanoma
ECOG-ACRIN Cancer Research Group
 2021-06-01 PHASE2
NCT04739566 WITHDRAWN
Thyroid Gland Anaplastic Carcinoma
Saint Petersburg State University, Russia
 2021-01-22 PHASE2
NCT03784014 COMPLETED
Soft Tissue Sarcoma
Institut National de la Santé Et de la Recherche Médicale, France
 2019-10-19 PHASE3
NCT04439292 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)
 2016-01-04 PHASE2
NCT04310397 TERMINATED
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8
M.D. Anderson Cancer Center
 2020-01-29 PHASE2
NCT02224781 ACTIVE_NOT_RECRUITING
Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Recurrent Melanoma; Unresectable Melanoma
National Cancer Institute (NCI)
 2015-09-08 PHASE3
NCT03455764 COMPLETED
Melanoma
Dana-Farber Cancer Institute
 2018-09-10 PHASE1; PHASE2
NCT04059224 COMPLETED
Stage IV Melanoma; Stage III Melanoma
Universitair Ziekenhuis Brussel
 2019-01-28 PHASE2
NCT03239015 UNKNOWN
Rare Tumor; Refractory Tumor
Baodong Qin
 2017-01-01 PHASE2
NCT05299580 WITHDRAWN
Melanoma
Fondazione Melanoma Onlus
 2021-02-18 PHASE2
NCT06079333 Recruiting
Anaplastic Thyroid Cancer
Leiden University Medical Center|Novartis
 2023-01-01 Phase 2
NCT04801966 TERMINATED
Cancer
Peter MacCallum Cancer Centre, Australia
 2021-09-23
NCT03668431 UNKNOWN
Metastatic Colorectal Cancer
Massachusetts General Hospital
 2018-10-15 PHASE2
NCT03244956 COMPLETED
Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
Gustave Roussy, Cancer Campus, Grand Paris
 2017-12-27 PHASE2
NCT06337617 Completed
BRAF V600 Mutation Positive Melanoma
Novartis Pharmaceuticals|Novartis
 2022-05-10 --
NCT01723202 COMPLETED
Follicular Thyroid Cancer; Insular Thyroid Cancer; Papillary Thyroid Cancer; Recurrent Thyroid Cancer
Bhavana Konda
 2012-11-07 PHASE2
NCT02858921 ACTIVE_NOT_RECRUITING
Melanoma
Melanoma Institute Australia
 2017-11-08 PHASE2
NCT03149029 ACTIVE_NOT_RECRUITING
Metastatic Melanoma
Massachusetts General Hospital
 2017-11-27 PHASE2
NCT02034110 COMPLETED
Cancer
Novartis Pharmaceuticals
 2014-03-12 PHASE2
NCT03754179 UNKNOWN
Melanoma
Universitair Ziekenhuis Brussel
 2018-01-23 PHASE1; PHASE2
NCT04554680 UNKNOWN
Thyroid Cancer
National University Hospital, Singapore
 2020-12-30 PHASE2
NCT04961619 Recruiting
Melanoma
Novartis Pharmaceuticals|Novartis
 2021-12-01 --
NCT04652258 TERMINATED
Pyrexia
University of Zurich
 2021-02-01 PHASE2
NCT02257424 COMPLETED
Advanced BRAF Mutant Melanoma
Abramson Cancer Center at Penn Medicine
 2014-10 PHASE1; PHASE2
NCT04547946 Completed
Malignant Melanoma
Novartis Pharmaceuticals|Novartis
 2021-10-15 --
NCT05171374 Recruiting
Melanoma Stage III|Melanoma Stage IV|Melanoma
MelanomaPRO Russia|Novartis
 2021-09-30 --
NCT02684058 COMPLETED
Diffuse Astrocytoma; Anaplastic Astrocytoma; Astrocytoma; Oligodendroglioma, Childhood; Anaplastic Oligodendroglioma; Glioblastoma; Pilocytic Astrocytoma; Giant Cell Astrocytoma; Pleomorphic Xanthoastrocytoma; Anaplastic Pleomorphic Xanthoastrocytoma; Angiocentric Glioma; Chordoid Glioma of Third Ventricle; Gangliocytoma; Ganglioglioma; Anaplastic Ganglioglioma; Dysplastic Gangliocytoma of Cerebrellum; Desmoplastic Infantile Astrocytoma and Ganglioglioma; Papillary Glioneuronal Tumor; Rosette-forming Glioneurona Tumor; Central Neurocytoma; Extraventricular Neurocytoma; Cerebellar Iponeurocytoma
Novartis Pharmaceuticals
 2017-12-28 PHASE2
NCT02130466 COMPLETED
Melanoma; Solid Tumors
Merck Sharp & Dohme LLC
 2014-05-29 PHASE1; PHASE2
NCT03332589 TERMINATED
Malignant Melanoma; Brain Metastases
Spirita Oncology, LLC
 2018-07-02 PHASE1
NCT03794297 WITHDRAWN
Erdheim-Chester Disease
National Cancer Institute (NCI)
 2019-01-04 PHASE2
NCT02124772 COMPLETED
Cancer
Novartis Pharmaceuticals
 2015-01-15 PHASE1; PHASE2
NCT03878524 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma
OHSU Knight Cancer Institute
 2020-04-01 PHASE1
NCT01677741 COMPLETED
Neoplasms, Brain
Novartis Pharmaceuticals
 2013-05-23 PHASE1; PHASE2
NCT03088176 UNKNOWN
Melanoma; BRAF Gene Mutation
West Cancer Center
 2017-06-25 PHASE1
NCT03551626 COMPLETED
Malignant Melanoma
Novartis Pharmaceuticals
 2018-08-29 PHASE3
NCT02967692 TERMINATED
Melanoma
Novartis Pharmaceuticals
 2017-02-17 PHASE3
NCT02974803 TERMINATED
Melanoma; Brain Metastases
Canadian Cancer Trials Group
 2018-02-09 PHASE2
NCT01940809 TERMINATED
BRAF V600E Mutation Present; BRAF V600K Mutation Present; 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
National Cancer Institute (NCI)
 2013-08-28 PHASE1
NCT03543306 UNKNOWN
Cancer; Lung Cancer Metastatic; BRAF V600E
Asan Medical Center
 2018-06-30 PHASE2
NCT01750918 COMPLETED
Cancer
Novartis Pharmaceuticals
 2012-12-19 PHASE1; PHASE2
NCT02700763 TERMINATED
Melanoma
University Medical Center Groningen
 2016-12-06
NCT03352947 COMPLETED
Melanoma
Cambridge University Hospitals NHS Foundation Trust
 2017-11-03 PHASE2
NCT03972046 WITHDRAWN
Melanoma (Skin); Melanoma Stage IIIb-IVM1a; Metastasis Skin; Tumor Skin; BRAF Gene Mutation
TriHealth Inc.
 2019-06-24 PHASE2
NCT02852239 COMPLETED
Renal Impairment
Novartis Pharmaceuticals
 2016-12-19 PHASE1
NCT02392871 COMPLETED
Metastatic Melanoma
Melanoma and Skin Cancer Trials Limited
 2015-05 PHASE1; PHASE2
NCT02672358 WITHDRAWN
Non-Small-Cell Lung Cancer
Novartis Pharmaceuticals
 2018-09-03 PHASE2
NCT03272464 TERMINATED
Melanoma
Massachusetts General Hospital
 2019-05-29 PHASE1
NCT01682213 COMPLETED
Melanoma
Memorial Sloan Kettering Cancer Center
 2012-09 PHASE2
NCT02097225 TERMINATED
BRAF V600E Mutation Present; BRAF V600K Mutation Present; Metastatic Malignant Solid Neoplasm; 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 Solid Neoplasm
National Cancer Institute (NCI)
 2014-05-29 PHASE1
NCT02110355 COMPLETED
Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors; Melanoma
Kartos Therapeutics, Inc.
 2014-12-19 PHASE1
NCT02367859 COMPLETED
Ameloblastoma; BRAF Gene Mutation
Stanford University
 2017-07-17 PHASE2
NCT02873650 TERMINATED
Hepatic Impairment
Novartis Pharmaceuticals
 2016-12-20 PHASE1
NCT02447939 WITHDRAWN
Melanoma
GlaxoSmithKline
 2017-05 PHASE1
NCT02281760 COMPLETED
BRAF V600E Mutation
National Human Genome Research Institute (NHGRI)
 2014-11-01 PHASE2
NCT03391050 TERMINATED
Melanoma
Aprea Therapeutics
 2018-01-18 PHASE1; PHASE2
NCT02410863 TERMINATED
Malignant Melanoma
Prof. Dr. med. Dirk Schadendorf
 2015-11 PHASE2
NCT02625337 UNKNOWN
Metastatic Melanoma
The Netherlands Cancer Institute
 2016-01 PHASE2
NCT01902173 COMPLETED
Hematopoietic and Lymphoid Cell Neoplasm; Locally Advanced Malignant Solid Neoplasm; Locally Advanced Melanoma; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Malignant Solid Neoplasm; Unresectable Melanoma
National Cancer Institute (NCI)
 2013-10-08 PHASE1; PHASE2
NCT02027961 COMPLETED
Melanoma
MedImmune LLC
 2013-12-20 PHASE1
NCT02083354 COMPLETED
Cancer; Melanoma
Novartis Pharmaceuticals
 2014-03-18 PHASE2
NCT02296996 COMPLETED
Malignant Melanoma
Universitair Ziekenhuis Brussel
 2014-10 PHASE2
NCT02143050 WITHDRAWN
Melanoma
University of Louisville
 2014-09 PHASE1; PHASE2
NCT01726738 COMPLETED
Stage III Melanoma; Stage IV Melanoma; Unresectable Melanoma; BRAF Mutant Melanoma
UNC Lineberger Comprehensive Cancer Center
 2013-04-04 PHASE2
NCT02915666 WITHDRAWN
Melanoma
University of Texas Southwestern Medical Center
 2016-10 PHASE1
NCT01682083 COMPLETED
Melanoma
Novartis Pharmaceuticals
 2013-01-08 PHASE3
NCT02039947 COMPLETED
Melanoma and Brain Metastases
Novartis Pharmaceuticals
 2014-02-21 PHASE2
NCT01972347 COMPLETED
Melanoma
Melanoma Institute Australia
 2014-10-01 PHASE2
NCT01978236 TERMINATED
Melanoma and Brain Metastases
GlaxoSmithKline
 2014-04-08 PHASE2
NCT02200562 TERMINATED
Stage III or IV Melanoma
University of Utah
 2014-12 PHASE1
NCT02314143 TERMINATED
Melanoma
GlaxoSmithKline
 2013-11-13 PHASE2
NCT01713972 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Manisha Shah
 2012-11-19 PHASE1
NCT02082665 COMPLETED
Cancer
GlaxoSmithKline
 2015-02-19 PHASE1
NCT01954043 COMPLETED
Cancer
GlaxoSmithKline
 2013-12-20 PHASE1
NCT01721603 TERMINATED
BRAFV600E Melanoma Patients
University of California, San Francisco
 2013-04 PHASE2
NCT01907802 TERMINATED
BRAF Gene Mutation; Hepatic Complication; Renal Failure; Solid Neoplasm
National Cancer Institute (NCI)
 2013-08-23 PHASE1
NCT01336634 COMPLETED
Cancer
Novartis Pharmaceuticals
 2011-08-05 PHASE2
NCT01767454 COMPLETED
Solid Tumours
GlaxoSmithKline
 2013-02-12 PHASE1
NCT02357732 WITHDRAWN
Metastatic Melanoma
University of Pittsburgh
 2015-08 PHASE1
NCT01701037 TERMINATED
Recurrent Melanoma; Stage IIB Melanoma (Locally Advanced); Stage IIC Melanoma (Locally Advanced); Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma (Limited, Resectable)
Vanderbilt-Ingram Cancer Center
 2013-01 PHASE2
NCT02052193 TERMINATED
Metastatic Melanoma (Carrying BRAF V600 Mutation)
University Hospital Tuebingen
 2014-01 PHASE2
NCT01928940 COMPLETED
Solid Tumours
GlaxoSmithKline
 2013-08-15 PHASE2
NCT01597908 COMPLETED
Melanoma
Novartis Pharmaceuticals
 2012-06-04 PHASE3
NCT01584648 COMPLETED
Melanoma
Novartis Pharmaceuticals
 2012-05-04 PHASE3
NCT01519427 TERMINATED
Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
 2012-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-03-26)

Check the Dabrafenib (GSK2118436) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dabrafenib selectively binds to and inhibits mutant BRAF V600E kinase with an IC50 of 0.7 nM, effectively suppressing downstream MAPK/ERK pathway signaling to arrest cellular proliferation and trigger apoptosis in mutation-bearing cancer cells. This pathway blockade inhibits driver-mutation-dependent tumor growth, providing the mechanistic rationale for its clinical activity in BRAF V600 mutation-positive melanoma, anaplastic thyroid cancer, 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.