Dabrafenib
- Generic Name
- Dabrafenib
- Brand Names
- Tafinlar, Finlee
- Drug Type
- Small Molecule
- Chemical Formula
- C23H20F3N5O2S2
- CAS Number
- 1195765-45-7
- Unique Ingredient Identifier
- QGP4HA4G1B
- Background
Dabrafenib mesylate (Tafinlar) is a reversible ATP-competitive kinase inhibitor and targets the MAPK pathway. It was approved on May 29, 2013, for the treatment of melanoma with V600E or V6000K mutation. It was also used for metastatic non-small cell lung cancer with the same mutation.
In May 2018, Tafinlar (dabrafenib), in combination with Mekinist (Trametinib), was approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene.
- Indication
As monotherapy, dabrafenib is indicated to treat unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
In combination with trametinib, dabrafenib is indicated to treat for:
Dabrafenib has limitations of use: it is neither indicated for treating patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition nor wild-type BRAF solid tumours.
- Associated Conditions
- Locally Advanced Anaplastic Thyroid Cancer, Low-Grade Glioma, Melanoma, Metastatic Anaplastic Thyroid Cancer, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Solid Tumours, Unresectable Melanoma, Unresectable Solid Tumor
Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma
- First Posted Date
- 2018-11-27
- Last Posted Date
- 2021-04-28
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Target Recruit Count
- 63
- Registration Number
- NCT03754179
- Locations
- 🇧🇪
UZ Brussel, Jette, Brabant, Belgium
Dabrafenib + Trametinib + PDR001 In Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- First Posted Date
- 2018-09-12
- Last Posted Date
- 2022-06-27
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 25
- Registration Number
- NCT03668431
- Locations
- 🇺🇸
Dana Farber Cancer Institite, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hosital Cancer Center, Boston, Massachusetts, United States
Melanoma Metastasized to the Brain and Steroids
- Conditions
- Malignant Melanoma
- Interventions
- First Posted Date
- 2018-06-20
- Last Posted Date
- 2023-07-13
- Lead Sponsor
- Inge Marie Svane
- Target Recruit Count
- 80
- Registration Number
- NCT03563729
- Locations
- 🇩🇰
Herlev Universityhospital, Herlev, Hovedstaden, Denmark
🇩🇰Aarhus Universityhospital, Aarhus, Midt, Denmark
🇩🇰Odense Universityhospital, Odense, Syd, Denmark
Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK
- Conditions
- Unresecable Stage IIIc or IV Melanoma
- First Posted Date
- 2018-06-12
- Last Posted Date
- 2018-06-12
- Lead Sponsor
- Poitiers University Hospital
- Target Recruit Count
- 20
- Registration Number
- NCT03553329
- Locations
- 🇫🇷
CHU DE Poitiers, Poitiers, France
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
- First Posted Date
- 2018-06-11
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 552
- Registration Number
- NCT03551626
- Locations
- 🇬🇧
Novartis Investigative Site, Southampton, United Kingdom
MCS110 With BRAF/MEK Inhibition in Patients With Melanoma
- First Posted Date
- 2018-03-07
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 6
- Registration Number
- NCT03455764
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
A Study of APR-246 in Combination With Dabrafenib in Resistant Patients With BRAF V600 Mutant Melanoma
- First Posted Date
- 2018-01-05
- Last Posted Date
- 2019-07-31
- Lead Sponsor
- Aprea Therapeutics
- Target Recruit Count
- 3
- Registration Number
- NCT03391050
- Locations
- 🇧🇪
Institut Jules Bordet, Bruxelles, Belgium
🇧🇪Universitair Ziekenhuis Antwerpen, Edegem, Belgium
🇧🇪CHU UCL Namur - site Sainte-Elisabeth, Namur, Belgium
Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
- First Posted Date
- 2017-11-24
- Last Posted Date
- 2020-12-08
- Target Recruit Count
- 79
- Registration Number
- NCT03352947
- Locations
- 🇬🇧
Addenbrooke's Hospital, Cambridge, England, United Kingdom
Dabrafenib and/or Trametinib Rollover Study
- Conditions
- MelanomaNon Small Cell Lung CancerSolid TumorRare CancersHigh Grade Glioma
- Interventions
- First Posted Date
- 2017-11-13
- Last Posted Date
- 2025-04-06
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 100
- Registration Number
- NCT03340506
- Locations
- 🇺🇸
Honor Health Research Institute, Scottsdale, Arizona, United States
🇺🇸National Institute Of Health, Bethesda, Maryland, United States
🇺🇸James Cancer Hospital and Solove Research Institute Ohio State, Columbus, Ohio, United States
E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)
- Conditions
- Brain MetastasesMalignant Melanoma
- Interventions
- First Posted Date
- 2017-11-06
- Last Posted Date
- 2022-05-20
- Lead Sponsor
- Spirita Oncology, LLC
- Target Recruit Count
- 4
- Registration Number
- NCT03332589
- Locations
- 🇺🇸
University of Arizona Cancer Center, Tucson, Arizona, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.