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

Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer

Phase 3

Active, not recruiting

Conditions: Differentiated Thyroid Cancer

Interventions: Drug: Dabrafenib
Drug: Trametinib placebo
Drug: Dabrafenib placebo
Drug: Trametinib

First Posted Date: 2021-06-25

Last Posted Date: 2025-05-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 153

Registration Number: NCT04940052

Locations: 🇺🇸
Northwestern University Med School, Chicago, Illinois, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇻🇳
Novartis Investigative Site, Hanoi, Vietnam

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Phase 1

Recruiting

Conditions: Metastatic Melanoma
BRAF Gene Mutation

Interventions: Drug: Nilotinib 100mg
Drug: Nilotinib 200mg
Drug: Nilotinib 300mg
Drug: Nilotinib 400mg
Drug: Dabrafenib
Drug: Trametinib
Drug: Encorafenib
Drug: Binimetinib

First Posted Date: 2021-05-26

Last Posted Date: 2025-03-07

Lead Sponsor: Ruta Arays

Target Recruit Count: 30

Registration Number: NCT04903119

Locations: 🇺🇸
Markey Cancer Center, Lexington, Kentucky, United States
🇺🇸
St. Luke's University Health Network, Easton, Pennsylvania, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Not Applicable

Terminated

Conditions: Cancer

Interventions: Drug: Trametinib
Drug: Cobimetinib
Drug: Binimetinib
Drug: Alpelisib
Drug: Vemurafenib
Drug: Dabrafenib
Drug: Encorafenib
Drug: Palbociclib
Drug: Olaparib
Drug: Ribociclib
Drug: Abemaciclib
Drug: Talazoparib
Drug: Nivolumab
Drug: Atezolizumab
Drug: Pembrolizumab

First Posted Date: 2021-03-17

Last Posted Date: 2023-05-10

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 3

Registration Number: NCT04801966

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer

Phase 2

Withdrawn

Conditions: Thyroid Gland Anaplastic Carcinoma

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2021-02-04

Last Posted Date: 2024-03-25

Lead Sponsor: Saint Petersburg State University, Russia

Registration Number: NCT04739566

Locations: 🇷🇺
Saint-Petersburg State University (SPSU) N.I.Pirogov Clinic of High Medical Technologies, Saint Petersburg, Russian Federation

Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

Phase 2

Active, not recruiting

Conditions: Thyroid Gland Anaplastic Carcinoma
Thyroid Gland Squamous Cell Carcinoma

Interventions: Procedure: Conventional Surgery
Drug: Dabrafenib
Radiation: Intensity-Modulated Radiation Therapy
Biological: Pembrolizumab
Other: Quality-of-Life Assessment
Drug: Trametinib

First Posted Date: 2020-12-19

Last Posted Date: 2025-02-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT04675710

Locations: 🇺🇸
Stanford School of Medicine, Stanford, California, United States
🇺🇸
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

and more 3 locations

Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

Recruiting

Conditions: Melanoma

Interventions: Drug: dabrafenib
Drug: trametinib

First Posted Date: 2020-12-14

Last Posted Date: 2024-06-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 80

Registration Number: NCT04666272

Locations: 🇨🇳
Novartis Investigative Site, Wuhan, China

Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment

Phase 1

Recruiting

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma

Interventions: Procedure: Biopsy Procedure
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Dabrafenib Mesylate
Procedure: Echocardiography Test
Procedure: Multigated Acquisition Scan
Drug: Tazemetostat Hydrobromide
Drug: Trametinib Dimethyl Sulfoxide

First Posted Date: 2020-09-22

Last Posted Date: 2025-05-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 58

Registration Number: NCT04557956

Locations: 🇺🇸
UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

and more 14 locations