Numerous clinical trials span Phase 1 through Phase 4 evaluations, including comparative combination studies, to investigate dabrafenib mesylate in BRAF V600-mutated malignancies such as metastatic melanoma, non-small-cell lung cancer, differentiated thyroid carcinoma, colorectal cancer, and central nervous system tumors like astrocytoma and glioblastoma. These protocols exhibit varied recruitment statuses—including active, recruiting, completed, terminated, and withdrawn—and are sponsored by both pharmaceutical leaders, such as Novartis Pharmaceuticals and GlaxoSmithKline, and academic institutions like the University of Arizona and Melanoma Institute Australia.
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT03176485 | Completed | Metastatic Cancer|Melanoma|Colon Cancer|Differentiated Thyroid Cancer|Hepatocellular Carcinoma|Renal Cell Carcinoma|Metastatic Melanoma|HCC|Metastatic Colon Cancer |
University of Arizona |
2014-10-17 | Not Applicable |
| 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 Mesylate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- Dabrafenib Mesylate Solubility in DMSO
- Dabrafenib Mesylate Stock Solution
- Dabrafenib Mesylate Storage
- Dabrafenib Mesylate Stability
- Dabrafenib Mesylate Molecular Weight
- Dabrafenib Mesylate SMILES
- Dabrafenib Mesylate CAS Number
- Dabrafenib Mesylate Chemical Structure (2D and 3D)
- Dabrafenib Mesylate SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.