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
A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration
- Conditions
- Low Grade Glioma of Brain With Neurofibromatosis Type 1High Grade Glioma (HGG) of the Brain With BRAF AberrationLow Grade Glioma (LGG) of Brain With BRAF Aberration
- Interventions
- First Posted Date
- 2019-12-17
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Pediatric Brain Tumor Consortium
- Target Recruit Count
- 57
- Registration Number
- NCT04201457
- Locations
- 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors.
- Conditions
- Malignant Solid Tumor
- Interventions
- First Posted Date
- 2019-10-04
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- Centre Leon Berard
- Target Recruit Count
- 455
- Registration Number
- NCT04116541
- Locations
- 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷Centre Léon Bérard, Lyon, France
🇫🇷Institut Paoli Calmettes, Marseille, France
TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma
- Conditions
- Stage III MelanomaStage IV Melanoma
- Interventions
- First Posted Date
- 2019-08-16
- Last Posted Date
- 2023-09-26
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Target Recruit Count
- 45
- Registration Number
- NCT04059224
- Locations
- 🇧🇪
Universitair Ziekenhuis Brussel, Jette, Brussels, Belgium
Pediatric Long-Term Follow-up and Rollover Study
- Conditions
- Diffuse AstrocytomaAnaplastic AstrocytomaAstrocytomaOligodendroglioma, ChildhoodAnaplastic OligodendrogliomaGlioblastomaPilocytic AstrocytomaGiant Cell AstrocytomaPleomorphic XanthoastrocytomaAnaplastic Pleomorphic Xanthoastrocytoma
- Interventions
- First Posted Date
- 2019-06-05
- Last Posted Date
- 2025-04-10
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 164
- Registration Number
- NCT03975829
- Locations
- 🇺🇸
Phoenix Children s Hospital, Phoenix, Arizona, United States
🇺🇸Childrens National Hospital, Washington, District of Columbia, United States
🇺🇸Nicklaus Childrens Hospital, Miami, Florida, United States
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
- Conditions
- BRAF NP_004324.2:p.V600EThyroid Gland Anaplastic CarcinomaBRAF V600K Mutation Present
- Interventions
- First Posted Date
- 2019-06-05
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 6
- Registration Number
- NCT03975231
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸Univ of Texas-M.D. Anderson Cancer Center, Houston, Texas, United States
🇺🇸Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma
- Conditions
- Melanoma (Skin)Metastasis SkinMelanoma Stage IIIb-IVM1aTumor SkinBRAF Gene Mutation
- Interventions
- Drug: Talimogene laherparepvec (T-Vec)
- First Posted Date
- 2019-06-03
- Last Posted Date
- 2020-10-19
- Lead Sponsor
- TriHealth Inc.
- Registration Number
- NCT03972046
- Locations
- 🇺🇸
TriHealth Cancer Institute - Kenwood, Cincinnati, Ohio, United States
BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients
- Conditions
- Melanoma
- First Posted Date
- 2019-05-09
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- EuMelaReg gGmbH
- Target Recruit Count
- 232
- Registration Number
- NCT03944356
- Locations
- 🇩🇪
Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Essen, Nordrhein-Westfalen, Germany
🇩🇪Elbe Kliniken Stade - Buxtehude GmbH, Buxtehude, Niedersachsen, Germany
🇩🇪Katholisches Klinikum Bochum, Bochum, Germany
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
- Conditions
- Anaplastic AstrocytomaAnaplastic Astrocytoma, Not Otherwise SpecifiedAnaplastic GangliogliomaAnaplastic Pleomorphic XanthoastrocytomaGlioblastomaMalignant GliomaWHO Grade 3 GliomaWHO Grade 4 Glioma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Lumbar PunctureProcedure: Magnetic Resonance ImagingRadiation: Radiation Therapy
- First Posted Date
- 2019-04-18
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 58
- Registration Number
- NCT03919071
- Locations
- 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸Banner Children's at Desert, Mesa, Arizona, United States
🇺🇸Phoenix Childrens Hospital, Phoenix, Arizona, United States
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAnatomic Stage IV Breast Cancer AJCC v8AnemiaAnn Arbor Stage III Hodgkin LymphomaAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage IV Hodgkin LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveCastration-Resistant Prostate Carcinoma
- Interventions
- Biological: BevacizumabProcedure: Biospecimen CollectionBiological: DurvalumabBiological: IpilimumabBiological: NivolumabBiological: PembrolizumabBiological: PertuzumabOther: Quality-of-Life AssessmentBiological: Trastuzumab Emtansine
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 2
- Registration Number
- NCT03878524
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations
- Conditions
- Erdheim-Chester Disease
- Interventions
- Other: Quality-of-Life AssessmentOther: Questionnaire Administration
- First Posted Date
- 2019-01-07
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Registration Number
- NCT03794297
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Drug Development Updates
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