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

PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

Phase 2

Active, not recruiting

Conditions: Thyroid Cancer, Follicular
Poorly Differentiated Thyroid Gland Carcinoma
Thyroid Cancer
Hurthle Cell Thyroid Neoplasia
Papillary Thyroid Cancer
Follicular Thyroid Cancer
Hurthle Cell Tumor

Interventions: Drug: Trametinib
Drug: Dabrafenib
Drug: PDR001

First Posted Date: 2020-09-10

Last Posted Date: 2025-05-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 19

Registration Number: NCT04544111

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, United States

and more 4 locations

Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma

Phase 2

Terminated

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Locally Advanced Melanoma
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Unresectable Melanoma
Pathologic Stage IV Cutaneous Melanoma AJCC v8

Interventions: Drug: Dabrafenib mesylate
Drug: Hydroxychloroquine
Drug: Placebo Administration
Drug: Trametinib dimethyl sulfoxide

First Posted Date: 2020-08-26

Last Posted Date: 2024-08-22

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 5

Registration Number: NCT04527549

Locations: 🇺🇸
MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States
🇺🇸
Bethesda North Hospital, Cincinnati, Ohio, United States
🇺🇸
TriHealth Cancer Institute-Westside, Cincinnati, Ohio, United States

and more 196 locations

Managed Access Program Cohort Treatment Plan CTMT212X2002I to Provide Access to Trametinib and Dabrafenib Combination Therapy for Patients With BRAF V600 Mutation-positive Advanced Non-Small Cell Lung Cancer

Conditions: Small Cell Lung Carcinoma

First Posted Date: 2020-08-11

Last Posted Date: 2024-11-11

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT04507919

Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melanoma

Conditions: Melanoma

First Posted Date: 2020-07-28

Last Posted Date: 2024-02-08

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT04489433

A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2020-07-01

Last Posted Date: 2025-02-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 40

Registration Number: NCT04452877

Locations: 🇨🇳
Novartis Investigative Site, Shanghai, China

Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Refractory Multiple Myeloma
Advanced Lymphoma
Refractory Lymphoma
Hematopoietic and Lymphoid Cell Neoplasm
Refractory Malignant Solid Neoplasm

Interventions: Drug: Dabrafenib Mesylate
Drug: Trametinib Dimethyl Sulfoxide

First Posted Date: 2020-06-19

Last Posted Date: 2025-02-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT04439292

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations

Phase 1

Suspended

Conditions: Solid Tumors

Interventions: Drug: JSI-1187
Drug: Dabrafenib

First Posted Date: 2020-06-05

Last Posted Date: 2024-02-02

Lead Sponsor: JS InnoPharm, LLC

Target Recruit Count: 71

Registration Number: NCT04418167

Locations: 🇺🇸
University of Arizona Comprehensive Cancer Center, Tucson, Arizona, United States
🇺🇸
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

and more 2 locations

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

Phase 2

Terminated

Conditions: Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Pathologic Stage IIID Cutaneous Melanoma AJCC v8

Interventions: Drug: Dabrafenib
Biological: Spartalizumab
Procedure: Therapeutic Conventional Surgery
Drug: Trametinib

First Posted Date: 2020-03-17

Last Posted Date: 2024-10-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 4

Registration Number: NCT04310397

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

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

Phase 1

Terminated

Conditions: BRAF V600 Colorectal Cancer

Interventions: Drug: Dabrafenib
Drug: LTT462
Drug: LXH254
Drug: TNO155
Drug: Trametinib
Biological: Spartalizumab
Biological: Tislelizumab

First Posted Date: 2020-03-03

Last Posted Date: 2024-11-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 122

Registration Number: NCT04294160

Locations: 🇺🇸
University of California LA Santa Monica Location, Los Angeles, California, United States
🇺🇸
Massachusetts General Hospital Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Sarah Cannon Research Institute SC, Nashville, Tennessee, United States

and more 2 locations

Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

Phase 2

Active, not recruiting

Conditions: Thyroid Cancer
BRAF Gene Mutation
Anaplastic Thyroid Cancer
BRAF Mutation-Related Tumors

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2020-01-23

Last Posted Date: 2025-04-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 16

Registration Number: NCT04238624

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

Drug Development Updates

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