Vemurafenib
- Generic Name
- Vemurafenib
- Brand Names
- Zelboraf
- Drug Type
- Small Molecule
- Chemical Formula
- C23H18ClF2N3O3S
- CAS Number
- 918504-65-1
- Unique Ingredient Identifier
- 207SMY3FQT
- Background
Vemurafenib is a competitive kinase inhibitor with activity against BRAF kinase with mutations like V600E. It exerts its function by binding to the ATP-binding domain of the mutant BRAF. Vemurafenib was co-developed by Roche and Plexxikon and it obtained its FDA approval on August 17, 2011, under the company Hoffmann La Roche. After approval, Roche in collaboration with Genentech launched a broad development program.
- Indication
Vemurafenib is approved since 2011 for the treatment of metastatic melanoma with a mutation on BRAF in the valine located in the exon 15 at codon 600, this mutation is denominated as V600E. The V600E mutation, a substitution of glutamic acid for valine, accounts for 54% of the cases of cutaneous melanoma.
Vemurafenib approval was extended in 2017, for its use as a treatment of adult patients with Erdheim-Chester Disease whose cancer cells present BRAF V600 mutation. Erdheim-Chester disease is an extremely rare histiocyte cell disorder that affects large bones, large vessels, central nervous system, as well as, skin and lungs. It is reported an association of Erdheim-Chester disease and V600E mutation.
- Associated Conditions
- Metastatic Melanoma, Refractory Lung Non-Small Cell Carcinoma, Unresectable Melanoma, Refractory Erdheim-Chester disease
A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site
- Conditions
- Cancer of Unknown Primary Site
- Interventions
- First Posted Date
- 2018-04-13
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 528
- Registration Number
- NCT03498521
- Locations
- 🇫🇷
Centre Antoine Lacassagne, Nice, France
🇫🇷Institut Curie, Paris, France
🇫🇷CHU Lyon - Centre Hospitalier Lyon Sud, Pierre-Benite (Lyon), France
Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases
- Conditions
- Malignant Melanoma Stage IVBRAF V600 MutationBrain Metastases
- Interventions
- First Posted Date
- 2018-02-13
- Last Posted Date
- 2023-09-14
- Lead Sponsor
- Technische Universität Dresden
- Target Recruit Count
- 20
- Registration Number
- NCT03430947
- Locations
- 🇩🇪
Technische Universität Dresden, Dresden, Germany
🇩🇪Ruprecht-Karls-University of Heidelberg, Faculty of Medicine, Heidelberg, Germany
🇩🇪Eberhard Karls University of Tübingen, University Medical Center, Tuebingen, Germany
A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
- Conditions
- Hairy Cell LeukemiaLeukemiaLeukemia, Hairy Cell
- Interventions
- First Posted Date
- 2018-01-25
- Last Posted Date
- 2025-02-11
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT03410875
- Locations
- 🇺🇸
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities), Commack, New York, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
- Conditions
- Lymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumors
- Interventions
- First Posted Date
- 2017-09-29
- Last Posted Date
- 2025-03-11
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 720
- Registration Number
- NCT03297606
- Locations
- 🇨🇦
London Health Sciences Centre Research Inc., London, Ontario, Canada
🇨🇦Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦BCCA - Kelowna, Kelowna, British Columbia, Canada
Efficacy and Safety of Precision Therapy in Refractory Tumor
- Conditions
- Rare TumorRefractory Tumor
- Interventions
- Drug: OxazolidineDrug: PD-1/L1 inhibitor plus anti-angiogenic agent
- First Posted Date
- 2017-08-03
- Last Posted Date
- 2022-03-04
- Lead Sponsor
- Baodong Qin
- Target Recruit Count
- 300
- Registration Number
- NCT03239015
- Locations
- 🇨🇳
Shanghai Changzheng Hospital, Shanghai, Shanghai, China
Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients
- Conditions
- MelanomaMelanoma (Skin)Melanoma Stage
- Interventions
- First Posted Date
- 2017-07-21
- Last Posted Date
- 2021-04-26
- Lead Sponsor
- Fondazione Melanoma Onlus
- Target Recruit Count
- 9
- Registration Number
- NCT03224208
- Locations
- 🇮🇹
Fondazione G.Pascale, Napoli, Italy
Vemurafenib and Cobimetinib in Treating Patients with BRAF V600E Mutation Positive Craniopharyngioma
- Conditions
- BRAF V600E Mutation PresentPapillary Craniopharyngioma
- Interventions
- Other: Laboratory Biomarker AnalysisOther: Quality-of-Life Assessment
- First Posted Date
- 2017-07-21
- Last Posted Date
- 2025-02-18
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 24
- Registration Number
- NCT03224767
- Locations
- 🇺🇸
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
🇺🇸Palo Alto Medical Foundation-Camino Division, Mountain View, California, United States
🇺🇸UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)
- Conditions
- Ann Arbor Stage III Childhood Non-Hodgkin LymphomaEwing SarcomaAdvanced Malignant Solid NeoplasmEpendymomaHepatoblastomaMalignant GliomaOsteosarcomaPeripheral Primitive Neuroectodermal TumorRecurrent Childhood Central Nervous System NeoplasmMalignant Germ Cell Tumor
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2017-07-18
- Last Posted Date
- 2025-01-27
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 4
- Registration Number
- NCT03220035
- Locations
- 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸Providence Alaska Medical Center, Anchorage, Alaska, United States
Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer
- Conditions
- Metastatic Thyroid Gland CarcinomaStage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8Poorly Differentiated Thyroid Gland CarcinomaStage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8Thyroid Gland Anaplastic CarcinomaUnresectable Thyroid Gland CarcinomaStage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8
- Interventions
- First Posted Date
- 2017-06-08
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 50
- Registration Number
- NCT03181100
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2017-06-07
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1000
- Registration Number
- NCT03178552
- Locations
- 🇵🇪
Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru
🇵🇪Instituto Peruano de Oncología y Radioterapia, Lima, Peru
🇵🇪Clinica Ricardo Palma, San Isidro, Peru
Drug Development Updates
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