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

Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)

Phase 2

Completed

Conditions: Solid Tumours

Interventions: Drug: dabrafenib
Drug: trametinib

First Posted Date: 2013-08-27

Last Posted Date: 2017-07-24

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 12

Registration Number: NCT01928940

Locations: 🇯🇵
GSK Investigational Site, Tokyo, Japan

Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction

Phase 1

Terminated

Conditions: Hepatic Complication
BRAF Gene Mutation
Solid Neoplasm
Renal Failure

Interventions: Drug: Dabrafenib
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Other: Pharmacological Study

First Posted Date: 2013-07-25

Last Posted Date: 2018-08-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 8

Registration Number: NCT01907802

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 15 locations

Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

Phase 1

Completed

Conditions: Unresectable Malignant Solid Neoplasm
Unresectable Melanoma
Locally Advanced Malignant Solid Neoplasm
Locally Advanced Melanoma
Metastatic Malignant Solid Neoplasm
Stage IIIC Cutaneous Melanoma AJCC v7
Hematopoietic and Lymphoid Cell Neoplasm
Metastatic Melanoma
Stage IV Cutaneous Melanoma AJCC v6 and v7

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib Mesylate
Procedure: Magnetic Resonance Imaging
Drug: Trametinib Dimethyl Sulfoxide
Drug: Uprosertib

First Posted Date: 2013-07-18

Last Posted Date: 2025-01-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 27

Registration Number: NCT01902173

Locations: 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States

and more 13 locations

Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma

Phase 1

Completed

Conditions: Solid Tumours

Interventions: Drug: Dabrafenib
Drug: Ipilimumab
Drug: Trametinib

First Posted Date: 2013-01-14

Last Posted Date: 2017-11-14

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 38

Registration Number: NCT01767454

Locations: 🇺🇸
GSK Investigational Site, Houston, Texas, United States

BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)

Phase 1

Completed

Conditions: Cancer

Interventions: Device: 5-fluorouracil
Drug: Dabrafenib
Drug: Panitumumab
Drug: Trametinib

First Posted Date: 2012-12-17

Last Posted Date: 2021-10-29

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 166

Registration Number: NCT01750918

Locations: 🇬🇧
Novartis Investigative Site, Birmingham, United Kingdom

LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations

Phase 2

Completed

Conditions: Stage IV Melanoma
Stage III Melanoma
Unresectable Melanoma
BRAF Mutant Melanoma

Interventions: Drug: BRAF inhibitor dabrafenib and MEK inhibitor trametinib

First Posted Date: 2012-11-15

Last Posted Date: 2020-11-23

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 17

Registration Number: NCT01726738

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, United States

Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer

Phase 2

Active, not recruiting

Conditions: Follicular Thyroid Cancer
Papillary Thyroid Cancer
Insular Thyroid Cancer
Recurrent Thyroid Cancer

Interventions: Drug: dabrafenib
Other: Correlative Studies
Drug: trametinib

First Posted Date: 2012-11-07

Last Posted Date: 2022-11-17

Lead Sponsor: Bhavana Konda

Target Recruit Count: 53

Registration Number: NCT01723202

Locations: 🇺🇸
The University of Texas-MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
University of California, San Diego, San Diego, California, United States

and more 2 locations

Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets

Phase 2

Terminated

Conditions: BRAFV600E Melanoma Patients

Interventions: Drug: Dabrafenib
Procedure: Gamma Knife Radiosurgery
Drug: Trametinib

First Posted Date: 2012-11-06

Last Posted Date: 2018-01-23

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 2

Registration Number: NCT01721603

Locations: 🇺🇸
University of San Francisco, California, San Francisco, California, United States

Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: dabrafenib
Drug: pazopanib hydrochloride
Other: Correlative studies

First Posted Date: 2012-10-25

Last Posted Date: 2019-03-01

Lead Sponsor: Manisha Shah

Target Recruit Count: 23

Registration Number: NCT01713972

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States
🇺🇸
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery

Phase 2

Terminated

Conditions: Stage IIIA Melanoma
Stage IIB Melanoma (Locally Advanced)
Recurrent Melanoma
Stage IIC Melanoma (Locally Advanced)
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma (Limited, Resectable)

Interventions: Drug: dabrafenib
Drug: trametinib
Other: laboratory biomarker analysis

First Posted Date: 2012-10-04

Last Posted Date: 2017-06-23

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 13

Registration Number: NCT01701037

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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