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

Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study

Phase 2

Terminated

Conditions: Metastatic Melanoma (Carrying BRAF V600 Mutation)

Interventions: Drug: Dabrafenib
Drug: Vemurafenib

First Posted Date: 2014-01-31

Last Posted Date: 2022-12-19

Lead Sponsor: University Hospital Tuebingen

Target Recruit Count: 8

Registration Number: NCT02052193

Locations: 🇩🇪
Department of Dermatology, Tuebingen, BW, Germany

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

Phase 2

Completed

Conditions: Melanoma and Brain Metastases

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2014-01-20

Last Posted Date: 2019-05-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 127

Registration Number: NCT02039947

Locations: 🇪🇸
Novartis Investigative Site, Zaragoza, Spain

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

Phase 2

Completed

Conditions: Cancer

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2014-01-13

Last Posted Date: 2023-08-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 206

Registration Number: NCT02034110

Locations: 🇸🇪
Novartis Investigative Site, Stockholm, Sweden

Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone

Phase 1

Completed

Conditions: Melanoma

Interventions: Biological: Durvalumab
Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2014-01-06

Last Posted Date: 2019-05-17

Lead Sponsor: MedImmune LLC

Target Recruit Count: 68

Registration Number: NCT02027961

Locations: 🇮🇹
Research Site, Napoli, Italy

Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma

Phase 1

Active, not recruiting

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Unresectable Melanoma
Malignant Solid Neoplasm

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib
Procedure: Echocardiography Test
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
Other: Pharmacological Study
Biological: Navitoclax
Drug: Trametinib

First Posted Date: 2013-11-21

Last Posted Date: 2025-05-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 75

Registration Number: NCT01989585

Locations: 🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States

and more 46 locations

Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites

Phase 2

Terminated

Conditions: Melanoma and Brain Metastases

Interventions: Drug: Dabrafenib 150 mg
Drug: Trametinib 2.0 mg

First Posted Date: 2013-11-07

Last Posted Date: 2018-08-17

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 6

Registration Number: NCT01978236

Locations: 🇦🇺
GSK Investigational Site, North Sydney, New South Wales, Australia

Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2013-10-30

Last Posted Date: 2025-01-23

Lead Sponsor: Melanoma Institute Australia

Target Recruit Count: 35

Registration Number: NCT01972347

Locations: 🇦🇺
Melanoma Institute Australia, North Sydney, New South Wales, Australia

A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: Dabrafenib 150 mg twice a day (BID)
Drug: Rabeprazole 40 mg once daily (OD)
Drug: Rifampin 600 mg OD

First Posted Date: 2013-10-01

Last Posted Date: 2017-11-14

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 23

Registration Number: NCT01954043

Locations: 🇬🇧
GSK Investigational Site, London, United Kingdom

Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery

Phase 1

Active, not recruiting

Conditions: Unresectable Thyroid Gland Carcinoma
Metastatic Thyroid Gland Carcinoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib
Drug: Dabrafenib Mesylate
Procedure: Echocardiography Test
Drug: Lapatinib
Drug: Lapatinib Ditosylate
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
Procedure: Positron Emission Tomography

First Posted Date: 2013-09-20

Last Posted Date: 2025-05-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 21

Registration Number: NCT01947023

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery

Phase 1

Terminated

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

Interventions: Biological: Ipilimumab
Drug: Dabrafenib
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Drug: Trametinib

First Posted Date: 2013-09-12

Last Posted Date: 2022-03-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 15

Registration Number: NCT01940809

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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