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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Clinical Trials
Related News

A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

First Posted Date
2016-11-18
Last Posted Date
2024-12-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
573
Registration Number
NCT02967692
Locations
🇺🇸

California Cancer Associates for Research and Excellence, Encinitas, California, United States

🇺🇸

UC Irvine Medical Center, Orange, California, United States

🇺🇸

Stanford Cancer Center, Stanford, California, United States

and more 15 locations

The Drug Rediscovery Protocol (DRUP Trial)

First Posted Date
2016-10-05
Last Posted Date
2024-01-24
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
1550
Registration Number
NCT02925234
Locations
🇳🇱

Meander medisch centrum, Amersfoort, Netherlands

🇳🇱

Netherlands Cancer Institute, Amsterdam, Netherlands

🇳🇱

Amsterdam UMC, locatie AMC, Amsterdam, Netherlands

and more 33 locations

A Clinical Trial of Patients With Melanoma

First Posted Date
2016-09-27
Last Posted Date
2018-05-15
Lead Sponsor
University of Texas Southwestern Medical Center
Registration Number
NCT02915666
Locations
🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

First Posted Date
2016-09-22
Last Posted Date
2024-10-30
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
52
Registration Number
NCT02910700
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment

Phase 1
Terminated
Conditions
Hepatic Impairment
Interventions
Drug: dabrafenib
First Posted Date
2016-08-19
Last Posted Date
2020-12-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
5
Registration Number
NCT02873650
Locations
🇺🇸

American Institute of Research, Los Angeles, California, United States

🇺🇸

Hassman Research Institute, Berlin, New Jersey, United States

🇺🇸

Wake Research Associates Oncology, Raleigh, North Carolina, United States

and more 1 locations

Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma

Phase 2
Active, not recruiting
Conditions
Melanoma
Interventions
Drug: Dabrafenib
Drug: Trametinib
Drug: Pembrolizumab
First Posted Date
2016-08-08
Last Posted Date
2023-08-30
Lead Sponsor
Melanoma Institute Australia
Target Recruit Count
60
Registration Number
NCT02858921
Locations
🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

🇦🇺

Westmead Hospital, Sydney, New South Wales, Australia

🇦🇺

Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia

Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment

Phase 1
Completed
Conditions
Renal Impairment
Interventions
Drug: dabrafenib
First Posted Date
2016-08-02
Last Posted Date
2020-12-09
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
22
Registration Number
NCT02852239
Locations
🇺🇸

Omega Research Consultants LLC, DeBary, Florida, United States

🇺🇸

Hassman Research Institute, Berlin, New Jersey, United States

🇺🇸

Wake Research Associates Oncology, Raleigh, North Carolina, United States

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors

First Posted Date
2016-02-17
Last Posted Date
2023-12-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
151
Registration Number
NCT02684058
Locations
🇺🇸

Ann and Robert H Lurie Childrens Hospital of Chicago ., Chicago, Illinois, United States

🇺🇸

Texas Children s Hospital Baylor College of Medicine, Houston, Texas, United States

🇺🇸

Children's Hospital of Orange County, Orange, California, United States

and more 8 locations

Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC

Phase 2
Withdrawn
Conditions
Non-Small-Cell Lung Cancer
Interventions
Drug: Dabrafenib
Drug: Trametinib
First Posted Date
2016-02-03
Last Posted Date
2018-08-10
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT02672358

Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients

First Posted Date
2015-12-09
Last Posted Date
2017-09-15
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
32
Registration Number
NCT02625337
Locations
🇳🇱

Antoni van Leeuwenhoek ziekenhuis, Amsterdam, NH, Netherlands

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