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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
Clinical Trials
Related News

A Clinical Trial of Patients With Melanoma

Phase 1
Withdrawn
Conditions
Melanoma
Interventions
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

Phase 2
Active, not recruiting
Conditions
Stage IV Cutaneous Melanoma AJCC v6 and v7
Unresectable Melanoma
Stage IIIA Cutaneous Melanoma AJCC v7
Metastatic Malignant Neoplasm in the Brain
Metastatic Melanoma
Stage III Cutaneous Melanoma AJCC v7
Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7
Interventions
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
First Posted Date
2016-09-22
Last Posted Date
2025-04-27
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
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

BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma

Phase 1
Completed
Conditions
Melanoma
Interventions
Drug: BGB324+pembrolizumab
First Posted Date
2016-08-19
Last Posted Date
2025-01-14
Lead Sponsor
Haukeland University Hospital
Target Recruit Count
74
Registration Number
NCT02872259
Locations
🇳🇴

St. Olavs Hospital, Trondheim, Norway

🇳🇴

Oslo University Hospital, Radiumhospitalet, Oslo, Norway

🇳🇴

Haukeland University Hospital, Bergen, Norway

and more 2 locations

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

Phase 2
Active, not recruiting
Conditions
Melanoma
Interventions
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
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

Phase 2
Completed
Conditions
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Pleomorphic Xanthoastrocytoma
Angiocentric Glioma
Giant Cell Astrocytoma
Anaplastic Pleomorphic Xanthoastrocytoma
Oligodendroglioma, Childhood
Glioblastoma
Astrocytoma
Pilocytic Astrocytoma
Interventions
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
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

Phase 2
Conditions
Metastatic Melanoma
Interventions
Procedure: Biopsy
Procedure: Blood taking
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

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2
Active, not recruiting
Conditions
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Bladder Carcinoma
Breast Carcinoma
Cervical Carcinoma
Colon Carcinoma
Colorectal Carcinoma
Endometrial Carcinoma
Esophageal Carcinoma
Exocrine Pancreas Carcinoma
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Other: Cytology Specimen Collection Procedure
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Procedure: Echocardiography Test
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Procedure: Radionuclide Imaging
First Posted Date
2015-06-08
Last Posted Date
2025-05-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
6452
Registration Number
NCT02465060
Locations
🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

🇺🇸

Thomas Hospital, Fairhope, Alabama, United States

🇺🇸

Mobile Infirmary Medical Center, Mobile, Alabama, United States

and more 1406 locations
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