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)
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>).
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