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
Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With Melanoma
- First Posted Date
- 2015-05-19
- Last Posted Date
- 2018-09-14
- Lead Sponsor
- GlaxoSmithKline
- Registration Number
- NCT02447939
Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma
- Conditions
- Melanoma
- First Posted Date
- 2015-04-14
- Last Posted Date
- 2017-08-15
- Lead Sponsor
- GlaxoSmithKline
- Registration Number
- NCT02416232
- Locations
- 🇫🇷
GSK Investigational Site, Villejuif cedex, France
Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma
- First Posted Date
- 2015-04-08
- Last Posted Date
- 2020-10-14
- Lead Sponsor
- Prof. Dr. med. Dirk Schadendorf
- Target Recruit Count
- 10
- Registration Number
- NCT02410863
- Locations
- 🇩🇪
University Hospital Tübingen, Tübingen, BW, Germany
🇩🇪National Centre for Tumour Diseases (NCT), Heidelberg, BW, Germany
🇩🇪Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden, Dresden, Saxony, Germany
Radiotherapy & Combi in Metastatic Melanoma
- Conditions
- Metastatic Melanoma
- Interventions
- Radiation: Palliative radiotherapy
- First Posted Date
- 2015-03-19
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Melanoma and Skin Cancer Trials Limited
- Target Recruit Count
- 10
- Registration Number
- NCT02392871
- Locations
- 🇦🇺
Princess Alexandra Hospital, Brisbane, Queensland, Australia
🇦🇺St Vincent's Hospital, Darlinghurst, New South Wales, Australia
🇦🇺Westmead Hospital, Sydney, New South Wales, Australia
Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma
- Conditions
- BRAF Gene MutationAmeloblastoma
- Interventions
- First Posted Date
- 2015-02-20
- Last Posted Date
- 2024-01-30
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 1
- Registration Number
- NCT02367859
- Locations
- 🇺🇸
Stanford University, School of Medicine, Stanford, California, United States
Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib
- Conditions
- Metastatic Melanoma
- Interventions
- First Posted Date
- 2015-02-06
- Last Posted Date
- 2015-12-11
- Lead Sponsor
- University of Pittsburgh
- Registration Number
- NCT02357732
Phase II Biomarker Study Comparing the Combination of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus the Combination After Monotherapy With Dabrafenib or Trametinib
- First Posted Date
- 2014-12-11
- Last Posted Date
- 2019-02-18
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 48
- Registration Number
- NCT02314143
- Locations
- 🇪🇸
GSK Investigational Site, Madrid, Spain
Dabrafenib and Trametinib for BRAF-inhibitor Pretreated Patients
- First Posted Date
- 2014-11-21
- Last Posted Date
- 2019-01-23
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Target Recruit Count
- 25
- Registration Number
- NCT02296996
- Locations
- 🇧🇪
UZ Brussel, Brussels, Belgium
Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease
- Conditions
- BRAF V600E Mutation
- Interventions
- First Posted Date
- 2014-11-04
- Last Posted Date
- 2021-08-31
- Lead Sponsor
- National Human Genome Research Institute (NHGRI)
- Target Recruit Count
- 9
- Registration Number
- NCT02281760
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma
- Conditions
- Advanced BRAF Mutant Melanoma
- Interventions
- First Posted Date
- 2014-10-06
- Last Posted Date
- 2022-01-20
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Target Recruit Count
- 50
- Registration Number
- NCT02257424
- Locations
- 🇺🇸
Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Drug Development Updates
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