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
PLATFORM Study of Precision Medicine for Rare Tumors
- Conditions
- Rare Tumor
- Interventions
- First Posted Date
- 2020-06-09
- Last Posted Date
- 2025-02-11
- Target Recruit Count
- 770
- Registration Number
- NCT04423185
- Locations
- 🇨🇳
Cancer hospital Chinese Academy of Medical Sciences, Beijing, China
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
- Conditions
- CancerTumorsNeoplasmsNeoplasia
- Interventions
- First Posted Date
- 2020-04-10
- Last Posted Date
- 2022-10-26
- Lead Sponsor
- Ulrik Lassen
- Target Recruit Count
- 300
- Registration Number
- NCT04341181
- Locations
- 🇩🇰
Aarhus University Hospital, Aarhus, Denmark
🇩🇰Rigshospitalet, Copenhagen, Denmark
🇩🇰Odense University Hospital, Odense, Denmark
A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Procedure: ResectionDrug: SBRTDrug: Chemotherapy
- First Posted Date
- 2020-03-10
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 125
- Registration Number
- NCT04302025
- Locations
- 🇺🇸
University of California Los Angeles - Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸Ellis Fischel Cancer Center, Columbia, Missouri, United States
🇺🇸UCSF Helen Diller Family CCC, San Francisco, California, United States
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAnatomic Stage IV Breast Cancer AJCC v8AnemiaAnn Arbor Stage III Hodgkin LymphomaAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage IV Hodgkin LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveCastration-Resistant Prostate Carcinoma
- Interventions
- Biological: BevacizumabProcedure: Biospecimen CollectionBiological: DurvalumabBiological: IpilimumabBiological: NivolumabBiological: PembrolizumabBiological: PertuzumabOther: Quality-of-Life AssessmentBiological: Trastuzumab Emtansine
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 2
- Registration Number
- NCT03878524
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation
- First Posted Date
- 2018-12-19
- Last Posted Date
- 2023-05-31
- Lead Sponsor
- Shanghai Kechow Pharma, Inc.
- Target Recruit Count
- 45
- Registration Number
- NCT03781219
- Locations
- 🇨🇳
First Affiliated Hospital, Medicine School of Zhejiang University, Hangzhou, Zhejiang, China
🇨🇳Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China
🇨🇳Henan Province Oncology Hospital, Zhengzhou, Henan, China
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
- Conditions
- Cancer
- Interventions
- First Posted Date
- 2018-12-07
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1000
- Registration Number
- NCT03768063
- Locations
- 🇩🇪
Universitaets-Hautklinik Tuebingen, Tübingen, Germany
🇩🇪Universitaettsklinikum Tübingen, Tübingen, Germany
🇩🇪Universitätsklinik Tübingen, Tübingen, Germany
Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT)
- First Posted Date
- 2018-11-01
- Last Posted Date
- 2021-08-19
- Lead Sponsor
- Shanghai Changzheng Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT03727763
- Locations
- 🇨🇳
Shanghai Changzheng Hospital, Shanghai, Shanghai, China
A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases
- Conditions
- Metastatic Melanoma
- Interventions
- First Posted Date
- 2018-08-10
- Last Posted Date
- 2024-04-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 80
- Registration Number
- NCT03625141
- Locations
- 🇧🇷
Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro, RJ, Brazil
🇧🇷Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, RS, Brazil
🇧🇷Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
A Combination of Vemurafenib, Cytarabine and 2-chlorodeoxyadenosine in Children With LCH and BRAF V600E Mutation
- Conditions
- Langerhans Cell Histiocytosis
- Interventions
- First Posted Date
- 2018-07-13
- Last Posted Date
- 2023-03-16
- Target Recruit Count
- 12
- Registration Number
- NCT03585686
- Locations
- 🇷🇺
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation
Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma
- Conditions
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Clinical Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Interventions
- First Posted Date
- 2018-06-12
- Last Posted Date
- 2025-04-24
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 59
- Registration Number
- NCT03554083
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
Drug Development Updates
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