Vemurafenib

Generic Name: Vemurafenib

Brand Names: Zelboraf

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₁₈ClF_₂N_₃O_₃S

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

Clinical Trials

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Phase 2

Recruiting

Conditions: Advanced Cancer
Solid Tumor
Haematological Malignancy

Interventions: Drug: Cobimetinib
Drug: Trastuzumab+Pertuzumab
Drug: Trametinib
Drug: Dabrafenib+Trametinib
Drug: Abemaciclib
Drug: Tepotinib
Drug: Dabrafenib
Drug: Pemigatinib
Drug: Regorafenib
Drug: Alectinib
Drug: Vismodegib
Drug: Entrectinib
Drug: Atezolizumab
Drug: Vemurafenib
Drug: Apalutamide

First Posted Date: 2021-12-16

Last Posted Date: 2024-07-15

Lead Sponsor: Helsinki University Central Hospital

Target Recruit Count: 250

Registration Number: NCT05159245

Locations: 🇫🇮
Turku University Hospital Cancer Centre, Turku, Varsinais-Suomi, Finland
🇫🇮
Kuopio University Hospital, Kuopio, Finland
🇫🇮
Oulu University Hospital OYS Cancer Center, Oulu, Finland

and more 2 locations

Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer

Phase 2

Recruiting

Conditions: Pancreas Cancer

Interventions: Drug: Vemurafenib
Drug: Sorafenib

First Posted Date: 2021-10-06

Last Posted Date: 2023-10-19

Lead Sponsor: HonorHealth Research Institute

Target Recruit Count: 12

Registration Number: NCT05068752

Locations: 🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States

Tolerability and Safety of Vemurafenib, Cetuximab Combined With Camrelizumab for BRAF V600E-mutated /MSS Metastatic Colorectal Cancer

Phase 1

Conditions: Vemurafenib (BRAFi) Plus Cetuximab (EGFRi) Combined With PD-1 Monoclonal Antibody
BRAF V600E-mutated /MSS Metastatic Colorectal Cancer

Interventions: Drug: Vemurafenib Oral Tablet [Zelboraf]
Drug: Cetuximab Injection [Erbitux]
Drug: Camrelizumab

First Posted Date: 2021-08-25

Last Posted Date: 2022-05-19

Lead Sponsor: West China Hospital

Target Recruit Count: 12

Registration Number: NCT05019534

Locations: 🇨🇳
Sichuan University West China Hospital, Chengdu, Sichuan, China

Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis

Phase 2

Recruiting

Conditions: Histiocytosis

Interventions: Drug: Vemurafenib

First Posted Date: 2021-06-29

Last Posted Date: 2025-04-13

Lead Sponsor: Anna Raciborska

Target Recruit Count: 25

Registration Number: NCT04943198

Locations: 🇵🇱
Mother and Child Institute, Warsaw, Mazovian, Poland

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Not Applicable

Terminated

Conditions: Cancer

Interventions: Drug: Trametinib
Drug: Cobimetinib
Drug: Binimetinib
Drug: Alpelisib
Drug: Vemurafenib
Drug: Dabrafenib
Drug: Encorafenib
Drug: Palbociclib
Drug: Olaparib
Drug: Ribociclib
Drug: Abemaciclib
Drug: Talazoparib
Drug: Nivolumab
Drug: Atezolizumab
Drug: Pembrolizumab

First Posted Date: 2021-03-17

Last Posted Date: 2023-05-10

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 3

Registration Number: NCT04801966

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: Cetuximab
Drug: Irinotecan
Drug: Vemurafenib

First Posted Date: 2021-03-10

Last Posted Date: 2023-02-15

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 37

Registration Number: NCT04790448

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Cobimetinib 20 MG Oral Tablet
Drug: Atezolizumab 1200 MG in 20 ML Injection
Drug: Vemurafenib 240 Mg Oral Capsule

First Posted Date: 2021-01-25

Last Posted Date: 2025-03-13

Lead Sponsor: Fondazione Melanoma Onlus

Target Recruit Count: 95

Registration Number: NCT04722575

Locations: 🇮🇹
Ospedale S.M. Annunziata - Azienda USL Toscana Centro, Bagno A Ripoli, Firenze, Italy
🇮🇹
IRCCS San Martino - IST, Genova, Italy
🇮🇹
Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori, Milano, Italy

and more 3 locations

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Phase 2

Active, not recruiting

Conditions: Other Cancer
Breast Cancer
Gastrointestinal Cancer
Non Small Cell Lung Cancer

First Posted Date: 2020-10-19

Last Posted Date: 2023-10-03

Lead Sponsor: Fondazione per la Medicina Personalizzata

Target Recruit Count: 400

Registration Number: NCT04591431

Locations: 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹
Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹
I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy

and more 34 locations

CRAFT: The NCT-PMO-1602 Phase II Trial

Phase 2

Completed

Conditions: Metastatic or Locally Advanced Malignancies

Interventions: Drug: Vemurafenib
Drug: Trastuzumab
Drug: Alectinib
Drug: Inavolisib
Drug: Ipatasertib
Drug: Cobimetinib
Drug: Pertuzumab
Drug: Atezolizumab

First Posted Date: 2020-09-16

Last Posted Date: 2025-01-08

Lead Sponsor: German Cancer Research Center

Target Recruit Count: 72

Registration Number: NCT04551521

Locations: 🇩🇪
Charité - Universitätsmedizin Berlin, Berlin, Germany
🇩🇪
Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg, Germany
🇩🇪
Universitätsklinikum Freiburg, Freiburg, Germany

and more 5 locations

Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers

Phase 1

Completed

Conditions: Thyroid Carcinoma
Thyroid Cancer
Thyroid Cancer, Follicular
Thyroid Cancer (Follicular Cell)
Thyroid Cancer, Papillary
BRAF V600E Mutation Positive

Interventions: Diagnostic Test: I-124 PET/CT lesion dosimetry
Drug: Vemurafenib
Drug: Copanlisib

First Posted Date: 2020-07-08

Last Posted Date: 2025-02-28

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 8

Registration Number: NCT04462471

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center (All protocol activities), New York, New York, United States
🇺🇸
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, United States

and more 4 locations

Drug Development Updates

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