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
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Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

Phase 3
Completed
Conditions
Interventions
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

Phase 2
Completed
Conditions
Interventions
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

Phase 1
Completed
Conditions
Interventions
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

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

Phase 3
Completed
Conditions
Interventions
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

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

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.

Phase 2
Completed
Conditions
Interventions
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

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