Dabrafenib

Generic Name: Dabrafenib

Brand Names: Tafinlar, Finlee

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₀F_₃N_₅O_₂S_₂

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

Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation

Phase 2

Active, not recruiting

Conditions: Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7

Interventions: Drug: Dabrafenib
Other: Laboratory Biomarker Analysis
Procedure: Therapeutic Conventional Surgery
Drug: Trametinib

First Posted Date: 2014-09-04

Last Posted Date: 2025-02-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 58

Registration Number: NCT02231775

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

Phase 3

Active, not recruiting

Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8
Recurrent Melanoma
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma
Unresectable Melanoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib Mesylate
Procedure: Echocardiography Test
Biological: Ipilimumab
Procedure: Multigated Acquisition Scan
Biological: Nivolumab
Other: Quality-of-Life Assessment
Drug: Trametinib Dimethyl Sulfoxide

First Posted Date: 2014-08-25

Last Posted Date: 2025-05-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 300

Registration Number: NCT02224781

Locations: 🇺🇸
Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
🇺🇸
Emory Decatur Hospital, Decatur, Georgia, United States
🇺🇸
CTCA at Western Regional Medical Center, Goodyear, Arizona, United States

and more 837 locations

Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread

Phase 2

Active, not recruiting

Conditions: Stage IV Cutaneous Melanoma AJCC v6 and v7
Unresectable Melanoma
Stage III Cutaneous Melanoma AJCC v7

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib Mesylate
Procedure: Echocardiography Test
Procedure: Multigated Acquisition Scan
Procedure: Positron Emission Tomography
Drug: Trametinib Dimethyl Sulfoxide

First Posted Date: 2014-07-21

Last Posted Date: 2025-05-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 280

Registration Number: NCT02196181

Locations: 🇺🇸
Kaiser Permanente-Oakland, Oakland, California, United States
🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

and more 752 locations

Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients

Phase 1

Withdrawn

Conditions: Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib
Drug: Metformin

First Posted Date: 2014-05-20

Last Posted Date: 2023-11-18

Lead Sponsor: University of Louisville

Registration Number: NCT02143050

Locations: 🇺🇸
James Graham Brown Cancer Center-Universityof Louisville, Louisville, Kentucky, United States
🇺🇸
James Graham Brown Cancer Center, Louisville, Kentucky, United States

A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022)

Phase 1

Completed

Conditions: Melanoma
Solid Tumors

Interventions: Biological: Pembrolizumab
Drug: Dabrafenib
Drug: Placebo
Drug: Trametinib

First Posted Date: 2014-05-05

Last Posted Date: 2022-08-01

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 184

Registration Number: NCT02130466

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: Trametinib
Drug: Dabrafenib

First Posted Date: 2014-04-28

Last Posted Date: 2021-07-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 139

Registration Number: NCT02124772

Locations: 🇬🇧
Novartis Investigative Site, London, United Kingdom

A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma

Phase 1

Completed

Conditions: Advanced Solid Tumors
Melanoma
Cancer
Oncology
Oncology Patients
Tumors
Advanced Malignancy

Interventions: Drug: AMG 232
Drug: Trametinib
Drug: Dabrafenib

First Posted Date: 2014-04-10

Last Posted Date: 2021-03-26

Lead Sponsor: Kartos Therapeutics, Inc.

Target Recruit Count: 31

Registration Number: NCT02110355

Locations: 🇦🇺
Research Site, Melbourne, Victoria, Australia

Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Phase 1

Terminated

Conditions: Metastatic Malignant Solid Neoplasm
Stage III Cutaneous Melanoma AJCC v7
BRAF V600E Mutation Present
Stage IV Cutaneous Melanoma AJCC v6 and v7
BRAF V600K Mutation Present
Stage IIIB Cutaneous Melanoma AJCC v7
Unresectable Solid Neoplasm
Metastatic Melanoma
Stage IIIA Cutaneous Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7

Interventions: Drug: Dabrafenib
Other: Laboratory Biomarker Analysis
Drug: Onalespib
Other: Pharmacological Study
Drug: Trametinib

First Posted Date: 2014-03-27

Last Posted Date: 2024-10-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 22

Registration Number: NCT02097225

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States