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.
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- 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:
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- 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
- Associated Therapies
- -
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
- Conditions
- Interventions
- Drug: AfatinibDrug: CapivasertibDrug: BinimetinibDrug: AdavosertibProcedure: Biospecimen CollectionOther: Cytology Specimen Collection ProcedureDrug: Afatinib DimaleateDrug: DabrafenibDrug: DefactinibDrug: FexagratinibDrug: DasatinibDrug: IpatasertibProcedure: BiopsyDrug: CrizotinibDrug: Dabrafenib MesylateDrug: TaselisibDrug: SapanisertibDrug: PI3K-beta Inhibitor GSK2636771Drug: Defactinib HydrochlorideDrug: PalbociclibBiological: NivolumabDrug: CopanlisibDrug: UlixertinibBiological: Trastuzumab EmtansineDrug: Copanlisib HydrochlorideBiological: RelatlimabProcedure: Computed TomographyDrug: TrametinibBiological: PertuzumabDrug: ErdafitinibProcedure: Radiologic ExaminationProcedure: Multigated Acquisition ScanDrug: LarotrectinibProcedure: EchocardiographyDrug: OsimertinibBiological: TrastuzumabDrug: Larotrectinib SulfateOther: Laboratory Biomarker AnalysisProcedure: Magnetic Resonance ImagingDrug: VismodegibDrug: Sunitinib MalateProcedure: Radionuclide Imaging
- First Posted Date
- 2015-06-08
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 6452
- Registration Number
- NCT02465060
- Locations
- 🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States
🇺🇸Anchorage Oncology Centre, Anchorage, Alaska, United States
🇺🇸Katmai Oncology Group, Anchorage, Alaska, United States
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
- 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
Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma
- Conditions
- 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
- 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 Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation
- Conditions
- Interventions
- First Posted Date
- 2014-09-04
- Last Posted Date
- 2024-07-26
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 58
- Registration Number
- NCT02231775
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients
- First Posted Date
- 2014-05-20
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- University of Louisville
- Registration Number
- NCT02143050
- Locations
- 🇺🇸
James Graham Brown Cancer Center-Universityof Louisville, Louisville, Kentucky, United States
🇺🇸James Graham Brown Cancer Center, Louisville, Kentucky, United States
A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022)
- Conditions
- Interventions
- First Posted Date
- 2014-05-05
- Last Posted Date
- 2022-08-01
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 184
- Registration Number
- NCT02130466
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.