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 Therapy With Conservative Surgery vs. Up-front Conservative Surgery for BRAF V600E-Mutated Ameloblastoma

Phase 2

Not yet recruiting

Conditions: Ameloblastoma

Interventions: Drug: Dabrafenib and trametinib (combination)

First Posted Date: 2025-02-11

Last Posted Date: 2025-02-11

Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Target Recruit Count: 46

Registration Number: NCT06819605

Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

Phase 2

Recruiting

Conditions: Solid Tumor
Precision Medicine

Interventions: Drug: Olaparib tablet
Drug: Target Gene
Drug: Temozolomide capsule
Drug: Anlotinib
Drug: Trametinib tablet
Drug: Dabrafenib
Drug: Vebreltinib Enteric Capsules
Drug: Alpelisib Pill
Drug: Sacituzumab Govitecan-Hziy 180 MG
Drug: Lenvatinib Capsules
Drug: Pazopanib Pill
Drug: Palbociclib Pill
Drug: Chidamide
Drug: PD-1/PD-L1/PD-1&CTLA4 inhibitor

First Posted Date: 2024-12-18

Last Posted Date: 2024-12-18

Lead Sponsor: Tianjin Medical University Second Hospital

Target Recruit Count: 300

Registration Number: NCT06739395

Locations: 🇨🇳
Tianjin Medical Unversity Second Hospital, Tianjin, Tianjin, China

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Phase 2

Recruiting

Conditions: Ameloblastoma
BRAF V600E Mutation Positive

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2024-10-22

Last Posted Date: 2024-10-22

Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Target Recruit Count: 12

Registration Number: NCT06653517

Locations: 🇨🇳
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting

Conditions: Hypogonadism, Male
NSCLC Stage IV
Sex Disorder
Erectile Dysfunction

Interventions: Drug: Alectinib
Drug: Osimertinib
Drug: Pembrolizumab
Drug: Cemiplimab
Drug: Brigatinib
Drug: Sotorasib
Drug: Lorlatinib 100 mg
Drug: Dabrafenib
Drug: Nivolumab
Drug: Trametinib
Drug: Carboplatin
Drug: Pemetrexed
Drug: Selpercatinib
Drug: Paclitaxel

First Posted Date: 2024-08-01

Last Posted Date: 2024-08-09

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 80

Registration Number: NCT06532149

Locations: 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Phase 2

Recruiting

Conditions: Locally Advanced Thyroid Gland Carcinoma

Interventions: Drug: Anlotinib
Drug: Lenvatinib
Drug: Sorafenib
Drug: Donafenib
Drug: Everolimus
Drug: Apatinib
Drug: Dabrafenib + Trametinib
Drug: Cabozantinib
Drug: Vandetanib
Drug: Entrectinib
Drug: Pralsetinib
Drug: Larotrectinib

First Posted Date: 2024-07-01

Last Posted Date: 2024-12-05

Lead Sponsor: West China Hospital

Target Recruit Count: 75

Registration Number: NCT06482086

Locations: 🇨🇳
West China hospital, Chengdu, Sichuan, China

Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

Phase 3

Recruiting

Conditions: Refractory Differentiated Thyroid Gland Carcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Cabozantinib
Drug: Dabrafenib
Procedure: Magnetic Resonance Imaging
Other: Questionnaire Administration
Drug: Trametinib

First Posted Date: 2024-06-26

Last Posted Date: 2024-11-18

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 264

Registration Number: NCT06475989

Locations: 🇺🇸
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
🇺🇸
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
🇺🇸
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint, Idaho, United States

and more 108 locations

Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy

Phase 2

Recruiting

Conditions: Anaplastic Thyroid Cancer

Interventions: Drug: Dabrafenib + Trametinib

First Posted Date: 2024-04-12

Last Posted Date: 2024-04-12

Lead Sponsor: Saint Petersburg State University, Russia

Target Recruit Count: 10

Registration Number: NCT06362694

Locations: 🇷🇺
Saint Petersburg State University Hospital, Saint Petersburg, Russian Federation

Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma

Phase 3

Not yet recruiting

Conditions: Ameloblastoma

Interventions: Drug: Dabrafenib

First Posted Date: 2024-02-20

Last Posted Date: 2024-02-20

Lead Sponsor: Shandong University

Target Recruit Count: 10

Registration Number: NCT06264778

A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer

Phase 4

Recruiting

Conditions: Advanced Thyroid Cancer Patients Who Received Target Therapy

Interventions: Drug: dabrafenib plus trametinib with or without PD-1 antibody
Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy
Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
Drug: anlotinib or anlotinib plus anti-PD-1 antibody
Drug: lenvatinib plus anti-PD-1 antibody

First Posted Date: 2024-01-08

Last Posted Date: 2024-04-30

Lead Sponsor: Fudan University

Target Recruit Count: 200

Registration Number: NCT06195228

Locations: 🇨🇳
Shanxi Cancer Hospital, Shanxi, Taiyuan, China
🇨🇳
Caixia Liu, Hohhot, Inner Mongolia, China
🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Precision Cancer Therapy in Rare Cancers

Phase 2

Recruiting

Conditions: Rare Malignant Neoplasm

Interventions: Drug: Imatinib
Drug: Trametinib
Drug: Dabrafenib

First Posted Date: 2023-11-07

Last Posted Date: 2025-03-26

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 96

Registration Number: NCT06119789

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway

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