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 With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
- First Posted Date
- 2012-09-10
- Last Posted Date
- 2023-08-30
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 870
- Registration Number
- NCT01682083
- Locations
- 🇬🇧
Novartis Investigative Site, Southampton, United Kingdom
Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation
- First Posted Date
- 2012-09-10
- Last Posted Date
- 2020-05-26
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 23
- Registration Number
- NCT01682213
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
- First Posted Date
- 2012-09-03
- Last Posted Date
- 2021-11-24
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 85
- Registration Number
- NCT01677741
- Locations
- 🇬🇧
Novartis Investigative Site, London, United Kingdom
An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients With Metastatic Melanoma Which is Refractory or Resistant to BRAF Inhibitor
- First Posted Date
- 2012-06-14
- Last Posted Date
- 2016-12-12
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 28
- Registration Number
- NCT01619774
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
- First Posted Date
- 2012-05-14
- Last Posted Date
- 2021-02-24
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 704
- Registration Number
- NCT01597908
- Locations
- 🇬🇧
Novartis Investigative Site, Swansea, United Kingdom
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
- Conditions
- Melanoma
- Interventions
- First Posted Date
- 2012-04-25
- Last Posted Date
- 2021-02-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 423
- Registration Number
- NCT01584648
- Locations
- 🇬🇧
Novartis Investigative Site, Preston, United Kingdom
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of of GSK2118436 in Japanese Subjects With BRAF Mutation Positive Solid Tumors
- First Posted Date
- 2012-04-23
- Last Posted Date
- 2017-11-13
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 12
- Registration Number
- NCT01582997
- Locations
- 🇯🇵
GSK Investigational Site, Tokyo, Japan
Re-differentiation of Radioiodine-Refractory BRAF V600E-mutant Papillary Thyroid Carcinoma With GSK2118436
- First Posted Date
- 2012-02-17
- Last Posted Date
- 2017-03-15
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 10
- Registration Number
- NCT01534897
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microtracer of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
- First Posted Date
- 2011-04-25
- Last Posted Date
- 2017-11-13
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 6
- Registration Number
- NCT01340833
- Locations
- 🇺🇸
GSK Investigational Site, Tacoma, Washington, United States
Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.
- First Posted Date
- 2011-04-18
- Last Posted Date
- 2022-04-04
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 177
- Registration Number
- NCT01336634
- Locations
- 🇬🇧
Novartis Investigative Site, Sutton, United Kingdom
Drug Development Updates
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