Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate vemurafenib across oncological indications, including metastatic melanoma, papillary thyroid carcinoma, hairy cell leukemia, non-small-cell lung carcinoma, and BRAF-mutated solid tumors. Sponsored by major pharmaceutical companies and academic institutions, these studies range from early safety evaluations to large randomized confirmatory trials. Across this research landscape, trial statuses include actively recruiting, completed, active non-recruiting, and terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05768178 RECRUITING
Haematological Malignancy; Melanoma; Thyroid Cancer, Papillary; Ovarian Neoplasms; Colorectal Neoplasms; Laryngeal Neoplasms; Carcinoma, Non-Small-Cell Lung; Glioma; Multiple Myeloma; Erdheim-Chester Disease; Thyroid Carcinoma, Anaplastic; Solid Tumour
Cancer Research UK
2023-03-01 PHASE2; PHASE3
NCT05722886 RECRUITING
Haematological Malignancy; Solid Tumour
Cancer Research UK
2023-03-01 PHASE2; PHASE3
NCT04341181 RECRUITING
Cancer; Tumors; Neoplasms; Neoplasia
Ulrik Lassen
2020-08-24 PHASE2
NCT03768063 ACTIVE_NOT_RECRUITING
Cancer
Hoffmann-La Roche
2019-02-28 PHASE3
NCT06692491 NOT_YET_RECRUITING
Rare Tumour
Peking University Shenzhen Hospital
2025-01-01 PHASE2
NCT02693535 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
American Society of Clinical Oncology
2016-03-14 PHASE2
NCT06561360 RECRUITING
Hairy Cell Leukemia
Memorial Sloan Kettering Cancer Center
2024-09-09 PHASE2
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
2016-08 PHASE2
NCT03181100 ACTIVE_NOT_RECRUITING
Metastatic Thyroid Gland Carcinoma; Poorly Differentiated Thyroid Gland Carcinoma; Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8; Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8; Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8; Thyroid Gland Anaplastic Carcinoma; Unresectable Thyroid Gland Carcinoma
M.D. Anderson Cancer Center
2017-07-27 PHASE2
NCT04943198 RECRUITING
Histiocytosis
Anna Raciborska
2021-04-01 PHASE2
NCT04943224 RECRUITING
Histiocytosis
Anna Raciborska
2021-04-01 PHASE2
NCT03178552 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Hoffmann-La Roche
2017-09-22 PHASE2; PHASE3
NCT03410875 ACTIVE_NOT_RECRUITING
Hairy Cell Leukemia; Leukemia; Leukemia, Hairy Cell
Memorial Sloan Kettering Cancer Center
2018-02-09 PHASE2
NCT03297606 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
Canadian Cancer Trials Group
2018-03-23 PHASE2
NCT06008119 RECRUITING
Colorectal Cancer Metastatic
Shanghai Kechow Pharma, Inc.
2023-10-25 PHASE3
NCT04302025 RECRUITING
Non-small Cell Lung Cancer
Genentech, Inc.
2020-11-06 PHASE2
NCT05159245 RECRUITING
Advanced Cancer; Solid Tumor; Haematological Malignancy
Helsinki University Central Hospital
2021-12-10 PHASE2
NCT06440850 RECRUITING
Thyroid Gland Follicular Carcinoma; Thyroid Gland Oncocytic Carcinoma; Thyroid Gland Papillary Carcinoma
City of Hope Medical Center
2024-07-15 PHASE2
NCT01709292 ACTIVE_NOT_RECRUITING
Thyroid Cancer
M.D. Anderson Cancer Center
2012-11-07 PHASE2
NCT06603376 RECRUITING
Colorectal Carcinoma
Shanghai Changzheng Hospital
2024-09-01 PHASE2
NCT04423185 RECRUITING
Rare Tumor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2020-08-15 PHASE2
NCT05238831 WITHDRAWN
Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
OHSU Knight Cancer Institute
2023-01-30 EARLY_PHASE1
NCT05388123 COMPLETED
Hairy Cell Leukemia
Scripps Health
2022-03-02 PHASE2
NCT02314481 COMPLETED
Non-small Cell Lung Cancer
University College, London
2017-05-12 PHASE2
NCT05900219 UNKNOWN
Non-small-cell Lung Cancer
Shanghai Kechow Pharma, Inc.
2023-09-24 PHASE2
NCT01638676 RECRUITING
Melanoma
University of Louisville
2012-07 PHASE1; PHASE2
NCT03554083 COMPLETED
Clinical Stage III Cutaneous Melanoma AJCC v8; 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
Mayo Clinic
2018-10-05 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
NCT04551521 COMPLETED
Metastatic or Locally Advanced Malignancies
German Cancer Research Center
2021-10-13 PHASE2
NCT04591431 UNKNOWN
Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer
Fondazione per la Medicina Personalizzata
2020-10-07 PHASE2
NCT02145143 COMPLETED
Thyroid Carcinoma
Memorial Sloan Kettering Cancer Center
2014-05-20 EARLY_PHASE1
NCT05068752 COMPLETED
Pancreas Cancer
HonorHealth Research Institute
2021-10-28 PHASE2
NCT05263453 UNKNOWN
Melanoma
Shanghai Kechow Pharma, Inc.
2021-09-06 PHASE2
NCT01711632 COMPLETED
Hairy Cell Leukemia
Memorial Sloan Kettering Cancer Center
2012-10 PHASE2
NCT02902029 COMPLETED
Malignant Melanoma
University Hospital, Essen
2016-11 PHASE2
NCT02036086 UNKNOWN
Melanoma
Sunnybrook Health Sciences Centre
2015-08 PHASE2
NCT05233332 UNKNOWN
CRC
Shanghai Kechow Pharma, Inc.
2022-02-24 PHASE2
NCT04722575 ACTIVE_NOT_RECRUITING
Melanoma
Fondazione Melanoma Onlus
2020-12-03 PHASE2
NCT03781219 UNKNOWN
Solid Tumor
Shanghai Kechow Pharma, Inc.
2018-07-01 PHASE1
NCT04462471 COMPLETED
Thyroid Carcinoma; Thyroid Cancer; Thyroid Cancer, Follicular; Thyroid Cancer (Follicular Cell); Thyroid Cancer, Papillary; BRAF V600E Mutation Positive
Memorial Sloan Kettering Cancer Center
2020-06-26 PHASE1
NCT03224767 ACTIVE_NOT_RECRUITING
BRAF V600E Mutation Present; Papillary Craniopharyngioma
Alliance for Clinical Trials in Oncology
2018-01-05 PHASE2
NCT03239015 UNKNOWN
Rare Tumor; Refractory Tumor
Baodong Qin
2017-01-01 PHASE2
NCT02091141 COMPLETED
Neoplasms; Solid Tumors; Biliary Cancer; Salivary Cancer; Bladder Cancer
Genentech, Inc.
2014-04-14 PHASE2
NCT03514901 UNKNOWN
Melanoma Metastatic; BRAF V600 Mutation
Intergruppo Melanoma Italiano
2018-06-18 PHASE2
NCT03585686 UNKNOWN
Langerhans Cell Histiocytosis
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
2018-06-26 PHASE2
NCT05768178 Recruiting
Solid Tumor|Haematological Malignancy|Melanoma|Thyroid Cancer Papillary|Ovarian Neoplasms|Colorectal Neoplasms|Laryngeal Neoplasms|Carcinoma Non-Small-Cell Lung|Glioma|Multiple Myeloma|Erdheim-Chester Disease|Thyroid Carcinoma Anaplastic
Cancer Research UK|University of Manchester|University of Birmingham|Royal Marsden NHS Foundation Trust|Hoffmann-La Roche
2023-03-01 Phase 2|Phase 3
NCT03498521 COMPLETED
Cancer of Unknown Primary Site
Hoffmann-La Roche
2018-07-10 PHASE2
NCT03430947 TERMINATED
Malignant Melanoma Stage IV; BRAF V600 Mutation; Brain Metastases
Technische Universität Dresden
2018-07-01 PHASE2
NCT04801966 TERMINATED
Cancer
Peter MacCallum Cancer Centre, Australia
2021-09-23
NCT02968303 UNKNOWN
Melanoma, Malignant, of Soft Parts
Radboud University Medical Center
2017-01-27 PHASE2
NCT05540951 UNKNOWN
Colorectal Cancer
Fudan University
2018-06-01 PHASE3
NCT05019534 UNKNOWN
BRAF V600E-mutated /MSS Metastatic Colorectal Cancer; Vemurafenib (BRAFi) Plus Cetuximab (EGFRi) Combined With PD-1 Monoclonal Antibody
West China Hospital
2021-08-15 PHASE1
NCT01843738 WITHDRAWN
BRAFV600 Mutation; Stage IV Melanoma
University of Utah
2017-06 PHASE1
NCT03220035 COMPLETED
Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma; Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma; Ependymoma; Ewing Sarcoma; Hepatoblastoma; Langerhans Cell Histiocytosis; Malignant Germ Cell Tumor; Malignant Glioma; Osteosarcoma; Peripheral Primitive Neuroectodermal Tumor; 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; Rhabdoid Tumor; Rhabdomyosarcoma; Soft Tissue Sarcoma; Wilms Tumor
National Cancer Institute (NCI)
2017-11-08 PHASE2
NCT01787500 COMPLETED
BRAF NP_004324.2:p.V600X; KRAS wt Allele; Metastatic Malignant Solid Neoplasm; Stage IV Colorectal Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7; Unresectable Solid Neoplasm
M.D. Anderson Cancer Center
2013-02-15 PHASE1
NCT04790448 COMPLETED
Colorectal Cancer Metastatic
Sun Yat-sen University
2020-07-27 PHASE1; PHASE2
NCT03727763 UNKNOWN
Colorectal Cancer
Shanghai Changzheng Hospital
2018-10-08 PHASE2
NCT02638428 UNKNOWN
Relapsed Pediatric Solid Tumor; Refractory Pediatric Solid Tumor; Relapsed Pediatric AML; Refractory Pediatric AML
Samsung Medical Center
2015-12 PHASE2
NCT01659151 COMPLETED
Metastatic Melanoma
H. Lee Moffitt Cancer Center and Research Institute
2012-08-03 PHASE2
NCT05068752 Recruiting
Pancreas Cancer
HonorHealth Research Institute|Bayer|Genentech Inc.
2021-10-28 Phase 2
NCT03625141 COMPLETED
Metastatic Melanoma
Hoffmann-La Roche
2018-12-13 PHASE2
NCT01531361 COMPLETED
Advanced Malignant Neoplasm; BRAF Gene Mutation; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm
M.D. Anderson Cancer Center
2012-02-06 PHASE1
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
NCT02414750 TERMINATED
Metastatic Melanoma
Netherlands Working Group on Immunotherapy of Oncology
2014-12 PHASE2
NCT03013491 TERMINATED
Solid Tumor; Lymphoma
CytomX Therapeutics
2017-01-19 PHASE1; PHASE2
NCT03101254 COMPLETED
Melanoma
Dana-Farber Cancer Institute
2017-06-06 PHASE1; PHASE2
NCT03224208 TERMINATED
Melanoma; Melanoma (Skin); Melanoma Stage
Fondazione Melanoma Onlus
2018-05-17 PHASE2
NCT01596140 COMPLETED
Advanced Cancer; Solid Tumor
M.D. Anderson Cancer Center
2012-12-18 PHASE1
NCT02303951 TERMINATED
Malignant Melanoma
University Hospital Tuebingen
2015-01-22 PHASE2
NCT01636622 COMPLETED
Advanced Cancers
M.D. Anderson Cancer Center
2012-07-09 PHASE1
NCT01656642 COMPLETED
Malignant Melanoma
Genentech, Inc.
2012-08-13 PHASE1
NCT01739764 COMPLETED
Neoplasms
Hoffmann-La Roche
2013-02-19 PHASE4
NCT02537600 COMPLETED
Malignant Melanoma
Center Eugene Marquis
2015-12 PHASE2
NCT02721459 ACTIVE_NOT_RECRUITING
Melanoma; Skin Cancer
H. Lee Moffitt Cancer Center and Research Institute
2016-09-07 PHASE1
NCT02908672 COMPLETED
Melanoma
Hoffmann-La Roche
2017-01-13 PHASE3
NCT02583516 COMPLETED
Melanoma
Grupo Español Multidisciplinar de Melanoma
2015-06-30 PHASE2
NCT02818023 TERMINATED
Melanoma
Yana Najjar
2016-07-13 PHASE1
NCT02145910 WITHDRAWN
Recurrent Melanoma; Stage IV Melanoma; Tumors Metastatic to Brain
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
PHASE1
NCT02291289 COMPLETED
Colorectal Cancer
Hoffmann-La Roche
2015-04-17 PHASE2
NCT01898585 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2013-10-17 PHASE4
NCT02304809 ACTIVE_NOT_RECRUITING
Solid Tumors; Hematologic Cancers; Metastatic Cancers
UNICANCER
2014-10-13 PHASE2
NCT02354690 COMPLETED
Metastatic Melanoma
Inge Marie Svane
2014-11 PHASE1; PHASE2
NCT01748149 COMPLETED
Pediatric Recurrent/Refractory BRAFV600E-mutant Gliomas
University of California, San Francisco
2014-04-29 EARLY_PHASE1
NCT02608034 COMPLETED
Metastatic Melanoma, BRAF V600 Mutation Positive
Genentech, Inc.
2016-05-26 PHASE1
NCT01876641 TERMINATED
Metastatic Melanoma; Melanoma; BRAF-mutated Metastatic Melanoma; V600EBRAF-mutated Metastatic Melanoma
Mohammed M Milhem
2013-10 PHASE1
NCT01959633 COMPLETED
Melanoma
Fondazione Melanoma Onlus
2014-04-03 PHASE1; PHASE2
NCT03005639 WITHDRAWN
Stage IIIB-C Melanoma
Inova Health Care Services
2017-06-01 PHASE2
NCT03410875 Active not recruiting
Hairy Cell Leukemia|Leukemia|Leukemia Hairy Cell
Memorial Sloan Kettering Cancer Center|Dana-Farber Cancer Institute|Yale University
2018-02-09 Phase 2
NCT01636908 COMPLETED
Cancer; Advanced Solid Tumors
Amsterdam UMC, location VUmc
2011-08
NCT02768207 COMPLETED
Metastatic Melanoma
Hoffmann-La Roche
2016-05-23 PHASE2
NCT03108209 COMPLETED
Phototoxicity
Michele Sayag
2016-07
NCT02164916 COMPLETED
Colorectal Cancer
SWOG Cancer Research Network
2014-11 PHASE2
NCT01603212 COMPLETED
Melanoma
M.D. Anderson Cancer Center
2013-07-18 PHASE1
NCT02115035 WITHDRAWN
Multiple Myeloma
University of Arkansas
2014-07 PHASE1; PHASE2
NCT01667419 COMPLETED
Melanoma
Hoffmann-La Roche
2012-09-24 PHASE3
NCT01767623 COMPLETED
Neoplasms
Hoffmann-La Roche
2013-08-20 PHASE1
NCT03013491 Completed
Solid Tumor|Lymphoma
CytomX Therapeutics
2017-01 Phase 1|Phase 2
NCT01909453 COMPLETED
Melanoma
Pfizer
2013-09-12 PHASE3
NCT01943422 COMPLETED
Melanoma
John Kirkwood
2013-10 PHASE1
NCT02427893 WITHDRAWN
Melanoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2015-08 PHASE3
NCT02202200 UNKNOWN
Melanoma BRAF V600E/K Mutated; CDNKN2A Loss Defined
Assistance Publique - Hôpitaux de Paris
2014-05 PHASE1; PHASE2
NCT01524978 COMPLETED
Multiple Myeloma, Neoplasms
Hoffmann-La Roche
2012-04-12 PHASE2
NCT02456701 COMPLETED
Thyroid Cancer
Celldex Therapeutics
2015-06 PHASE1
NCT01771458 COMPLETED
Reccurent/Metastatic Solid Tumor Disease
Institut Curie
2012-10 PHASE2
NCT01657591 COMPLETED
Melanoma
H. Lee Moffitt Cancer Center and Research Institute
2012-07-27 PHASE1
NCT02441465 COMPLETED
Malignant Melanoma, Cancer
Hoffmann-La Roche
2015-08-13 PHASE1
NCT01813214 TERMINATED
Melanoma
Georgetown University
2013-03 PHASE2
NCT01585415 TERMINATED
Metastatic Cancer; Melanoma
National Cancer Institute (NCI)
2012-04-09 PHASE1
NCT01897116 COMPLETED
Melanoma
Abramson Cancer Center at Penn Medicine
2013-06 PHASE1
NCT02230306 TERMINATED
Active Melanoma Brain Metastases
Melissa Burgess, MD
2015-02 PHASE2
NCT01307397 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2011-03-01 PHASE3
NCT01495988 TERMINATED
Melanoma; Metastatic Melanoma
Melanoma Research Foundation Breakthrough Consortium
2013-08 PHASE2
NCT01519323 TERMINATED
Malignant Melanoma
Hoffmann-La Roche
2013-01 PHASE1
NCT02068079 WITHDRAWN
Melanoma
Duke University
2014-04 PHASE1
NCT01765543 COMPLETED
Malignant Melanoma, Neoplasms
Hoffmann-La Roche
2013-07 PHASE1
NCT01942993 TERMINATED
Melanoma
Philip Friedlander
2013-09 PHASE2
NCT01378975 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2011-07 PHASE2
NCT00405587 COMPLETED
Malignant Melanoma; Colorectal Carcinoma
Plexxikon
2006-11 PHASE1
NCT01586195 TERMINATED
Malignant Melanoma
Genentech, Inc.
2011-10-31 PHASE2
NCT01791309 COMPLETED
Metastatic Colorectal Cancer
Memorial Sloan Kettering Cancer Center
2013-01 PHASE1
NCT01841463 SUSPENDED
Advanced or Inoperable Malignant Melanoma With BRAF Mutation
Piramal Enterprises Limited
2013-08 PHASE1
NCT01673737 COMPLETED
Neoplasm Malignant
Sanofi
2012-08 PHASE1
NCT01754376 TERMINATED
Melanoma
Massachusetts General Hospital
2013-01 PHASE2
NCT02050321 TERMINATED
Malignant Melanoma
University of Arizona
2013-12 PHASE2
NCT01616199 TERMINATED
Advanced BRAF-mutant Cancers
Cascadian Therapeutics Inc.
2012-08 PHASE1; PHASE2
NCT02052193 TERMINATED
Metastatic Melanoma (Carrying BRAF V600 Mutation)
University Hospital Tuebingen
2014-01 PHASE2
NCT01683188 TERMINATED
Metastatic Melanoma
Clinigen, Inc.
2012-08 PHASE4
NCT01286753 COMPLETED
Neoplasms
Hoffmann-La Roche
2011-06 PHASE2
NCT01826448 TERMINATED
V600-mutated BRAF Unresectable Melanoma; V600-mutated BRAF Metastatic Melanoma; Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
Daiichi Sankyo
2013-11-05 PHASE1
NCT01835184 TERMINATED
Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2013-05 PHASE1
NCT02077114 COMPLETED
Malignant Melanoma With Metastasis
Herlev Hospital
2014-02 PHASE1
NCT01844674 COMPLETED
Malignant Melanoma, Neoplasms
Hoffmann-La Roche
2013-09-02 PHASE1
NCT01673854 COMPLETED
Melanoma
Bristol-Myers Squibb
2012-09-13 PHASE2
NCT01974258 WITHDRAWN
Neoplasms
Hoffmann-La Roche
2014-02 PHASE1
NCT01781026 COMPLETED
Melanoma
Yale University
2013-04 PHASE2
NCT01851824 COMPLETED
Malignant Melanoma, Neoplasms
Hoffmann-La Roche
2013-08 PHASE1
NCT01765569 COMPLETED
Malignant Melanoma, Neoplasms
Hoffmann-La Roche
2013-07 PHASE1
NCT01689519 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2013-01-08 PHASE3
NCT01597908 COMPLETED
Melanoma
Novartis Pharmaceuticals
2012-06-04 PHASE3
NCT01849666 COMPLETED
Malignant Melanoma, Neoplasms
Hoffmann-La Roche
2013-09 PHASE1
NCT01983124 COMPLETED
Malignant Melanoma Stage IV
Paola Queirolo
2013-02 PHASE2
NCT01611675 TERMINATED
Melanoma
Massachusetts General Hospital
2012-07 PHASE1
NCT01512251 COMPLETED
BRAF Mutant Metastatic Melanoma
University of California, San Francisco
2012-06-09 PHASE1; PHASE2
NCT01910181 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2013-08-17 PHASE1
NCT01271803 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2011-02-17 PHASE1
NCT01765556 WITHDRAWN
Malignant Melanoma, Neoplasms
Hoffmann-La Roche
2013-10 PHASE1
NCT01519427 TERMINATED
Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2012-01 PHASE2
NCT01400451 TERMINATED
Melanoma
Bristol-Myers Squibb
2011-11 PHASE1
NCT01474551 TERMINATED
Melanoma
Memorial Sloan Kettering Cancer Center
2011-11 PHASE2
NCT01006980 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2010-01 PHASE3
NCT00949702 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2009-09-30 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-11-24)

Check the PLX4032 (Vemurafenib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vemurafenib selectively binds to the ATP-binding domain of the mutated BRAF V600E kinase, inhibiting its constitutive enzymatic activity and blocking downstream MEK and ERK phosphorylation within the MAPK pathway. This targeted signaling blockade suppresses tumor cellular proliferation and induces apoptosis, driving tumor regression in clinical trial populations with BRAF V600E-mutated malignancies such as melanoma, hairy cell leukemia, 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.