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 collab...
- 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.
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- Associated Conditions
- Metastatic Melanoma, Refractory Lung Non-Small Cell Carcinoma, Unresectable Melanoma, Refractory Erdheim-Chester disease
- Associated Therapies
- -
Cabozantinib-S-Malate and Vemurafenib in Treating Patients With Solid Tumors or Melanoma That is Metastatic or That Cannot Be Removed By Surgery
- First Posted Date
- 2013-04-18
- Last Posted Date
- 2014-09-25
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 5
- Registration Number
- NCT01835184
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸Virginia Commonwealth University, Richmond, Virginia, United States
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
- First Posted Date
- 2013-04-08
- Last Posted Date
- 2020-05-28
- Lead Sponsor
- Daiichi Sankyo
- Target Recruit Count
- 13
- Registration Number
- NCT01826448
- Locations
- 🇺🇸
University of Colorado, Denver, Aurora, Colorado, United States
🇺🇸Vanderbilt University, Nashville, Tennessee, United States
🇺🇸Seattle Cancer Care Alliance, Seattle, Washington, United States
The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma
- First Posted Date
- 2013-03-18
- Last Posted Date
- 2019-02-26
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 5
- Registration Number
- NCT01813214
- Locations
- 🇺🇸
Georgetown Lombardi Comprehsnive Cancer Center, Washington, District of Columbia, United States
🇺🇸University of Virginia Health System, Charlottesville, Virginia, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery
- Conditions
- Interventions
- First Posted Date
- 2013-02-08
- Last Posted Date
- 2024-03-20
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 33
- Registration Number
- NCT01787500
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases
- First Posted Date
- 2013-01-31
- Last Posted Date
- 2017-03-10
- Lead Sponsor
- Yale University
- Target Recruit Count
- 2
- Registration Number
- NCT01781026
- Locations
- 🇺🇸
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States
A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
- First Posted Date
- 2013-01-14
- Last Posted Date
- 2018-02-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 8
- Registration Number
- NCT01767623
- Locations
- 🇺🇸
California Cancer Associates for Research & Excellence, Inc., Encinitas, California, United States
🇬🇧Velindre Cancer Centre, Cardiff, United Kingdom
🇦🇺Peninsula and South Eastern Haematology and Oncology Grou, Frankston, Victoria, Australia
A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
- First Posted Date
- 2013-01-10
- Last Posted Date
- 2015-09-23
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 29
- Registration Number
- NCT01765569
A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
- First Posted Date
- 2013-01-10
- Last Posted Date
- 2016-12-15
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 27
- Registration Number
- NCT01765543
A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
- Conditions
- Interventions
- First Posted Date
- 2013-01-10
- Last Posted Date
- 2016-11-02
- Lead Sponsor
- Hoffmann-La Roche
- Registration Number
- NCT01765556
Combined BRAF-Targeted Therapy & Immunotherapy for Melanoma
- First Posted Date
- 2012-12-21
- Last Posted Date
- 2017-04-12
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 6
- Registration Number
- NCT01754376
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Drug Development Updates
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