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

Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

Phase 2

Not yet recruiting

Conditions: NSCLC
MET Exon 14 Mutation
BRAF V600 Mutation

Interventions: Drug: Dabrafenib + Trametinib
Drug: Capmatinib

First Posted Date: 2023-09-26

Last Posted Date: 2023-10-10

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 40

Registration Number: NCT06054191

Locations: 🇨🇳
Cancer Center of Sun-Yat Sen University, Guangzhou, Guangdong, China

Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations

Phase 2

Recruiting

Conditions: Cancer

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2023-05-25

Last Posted Date: 2023-11-30

Lead Sponsor: Se Jun Park

Target Recruit Count: 30

Registration Number: NCT05876806

Locations: 🇰🇷
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea, Republic of

Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Completed

Conditions: Melanoma

Interventions: Drug: Dabrafenib + trametinib
Drug: Nivolumab
Drug: Ipilimumab + nivolumab
Drug: Pembrolizumab

First Posted Date: 2023-02-06

Last Posted Date: 2023-02-06

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 618

Registration Number: NCT05714371

Locations: 🇺🇸
Novartis Pharmaceuticals, East Hanover, New Jersey, United States

E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases from BRAF V600 Mutated Metastatic Melanoma

Phase 1

Active, not recruiting

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC V8
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Neoplasm in the Central Nervous System
Metastatic Melanoma

Interventions: Drug: Dabrafenib
Drug: MEK-1/MEKK-1 Inhibitor E6201
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging

First Posted Date: 2022-05-24

Last Posted Date: 2025-02-06

Lead Sponsor: Mayo Clinic

Target Recruit Count: 18

Registration Number: NCT05388877

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"

Phase 2

Withdrawn

Conditions: Melanoma

Interventions: Drug: dabrafenib
Drug: Trametinib

First Posted Date: 2022-03-29

Last Posted Date: 2023-09-14

Lead Sponsor: Fondazione Melanoma Onlus

Registration Number: NCT05299580

Locations: 🇮🇹
National Institute of Cancer, Bari, Italy
🇮🇹
IRCCS San Martino - IST, Genova, Italy
🇮🇹
Azienda Ospedaliera Universitaria di Modena, Modena, Italy

and more 13 locations

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Completed

Conditions: Melanoma

Interventions: Drug: Encorafenib
Drug: Dabrafenib
Drug: Vemurafenib
Drug: Binimetinib
Drug: Cobimetinib
Drug: Trametinib

First Posted Date: 2022-03-02

Last Posted Date: 2025-03-06

Lead Sponsor: Pfizer

Target Recruit Count: 716

Registration Number: NCT05260684

Locations: 🇺🇸
Pfizer Investigational Site, New York, New York, United States

A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)

Phase 2

Recruiting

Conditions: Thyroid Cancer

Interventions: Drug: Dabrafenib 75 MG
Drug: Trametinib 2 MG

First Posted Date: 2022-01-10

Last Posted Date: 2023-10-31

Lead Sponsor: Olivia Newton-John Cancer Research Institute

Target Recruit Count: 80

Registration Number: NCT05182931

Locations: 🇦🇺
Royal Adelaide Hsopital, Adelaide, South Australia, Australia
🇦🇺
Austin Health, Heidelberg, Victoria, Australia
🇦🇺
Sir Charles Gairdner Hospital, Perth, Western Australia, Australia

and more 6 locations

pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE

Recruiting

Conditions: Melanoma Stage III
Melanoma Stage IV
Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2021-12-28

Last Posted Date: 2022-06-01

Lead Sponsor: MelanomaPRO, Russia

Target Recruit Count: 500

Registration Number: NCT05171374

Locations: 🇷🇺
Republican Clinical Oncology Center of Chuvashia, Cheboksary, Chuvash Republic,, Russian Federation
🇷🇺
GBUZ Yuzhno-Sakhalinsk oncologic dispensary, Yuzhno-Sakhalinsk, Russian Federation
🇷🇺
Irkutsk Regional Oncological Dispensary, Irkutsk, Irkutsk Region, Russian Federation

and more 12 locations

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Phase 2

Recruiting

Conditions: Advanced Cancer
Solid Tumor
Haematological Malignancy

Interventions: Drug: Cobimetinib
Drug: Trastuzumab+Pertuzumab
Drug: Trametinib
Drug: Dabrafenib+Trametinib
Drug: Abemaciclib
Drug: Tepotinib
Drug: Dabrafenib
Drug: Pemigatinib
Drug: Regorafenib
Drug: Alectinib
Drug: Vismodegib
Drug: Entrectinib
Drug: Atezolizumab
Drug: Vemurafenib
Drug: Apalutamide

First Posted Date: 2021-12-16

Last Posted Date: 2024-07-15

Lead Sponsor: Helsinki University Central Hospital

Target Recruit Count: 250

Registration Number: NCT05159245

Locations: 🇫🇮
Turku University Hospital Cancer Centre, Turku, Varsinais-Suomi, Finland
🇫🇮
Kuopio University Hospital, Kuopio, Finland
🇫🇮
Oulu University Hospital OYS Cancer Center, Oulu, Finland

and more 2 locations

Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

Completed

Conditions: Melanoma

Interventions: Drug: dabrafenib
Drug: trametinib

First Posted Date: 2021-07-14

Last Posted Date: 2025-01-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 39

Registration Number: NCT04961619

Locations: 🇹🇷
Novartis Investigative Site, Kecioren Ankara, Turkey

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