Dabrafenib

Generic Name
Dabrafenib
Brand Names
Tafinlar, Finlee
Drug Type
Small Molecule
Chemical Formula
C23H20F3N5O2S2
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.
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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:
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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
Associated Therapies
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Clinical Trials
Related News

Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer

First Posted Date
2019-06-05
Last Posted Date
2024-10-09
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
6
Registration Number
NCT03975231
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

Univ of Texas-M.D. Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Pediatric Long-Term Follow-up and Rollover Study

First Posted Date
2019-06-05
Last Posted Date
2024-11-14
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
166
Registration Number
NCT03975829
Locations
🇺🇸

Phoenix Children s Hospital, Phoenix, Arizona, United States

🇺🇸

Childrens National Hospital, Washington, District of Columbia, United States

🇺🇸

Nicklaus Childrens Hospital, Miami, Florida, United States

and more 9 locations

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1
Terminated
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma
Interventions
Drug: Abemaciclib
Drug: Abiraterone
Drug: Afatinib
Biological: Bevacizumab
Drug: Bicalutamide
Procedure: Biospecimen Collection
Drug: Bortezomib
Drug: Cabazitaxel
Drug: Cabozantinib
Drug: Capecitabine
Drug: Carboplatin
Drug: Celecoxib
Drug: Cobimetinib
Drug: Copanlisib
Drug: Dabrafenib
Drug: Dacomitinib
Drug: Darolutamide
Drug: Dasatinib
Drug: Doxorubicin
Biological: Durvalumab
Drug: Enasidenib
Drug: Entrectinib
Drug: Enzalutamide
Drug: Erlotinib
Drug: Everolimus
Drug: Fluorouracil
Drug: Idelalisib
Drug: Imatinib
Biological: Ipilimumab
Drug: Lenvatinib
Drug: Leucovorin
Drug: Lorlatinib
Drug: Losartan
Drug: Nab-paclitaxel
Drug: Neratinib
Biological: Nivolumab
Drug: Olaparib
Drug: Oxaliplatin
Drug: Palbociclib
Drug: Panobinostat
Biological: Pembrolizumab
Biological: Pertuzumab
Drug: Ponatinib
Other: Quality-of-Life Assessment
Drug: Regorafenib
Drug: Ruxolitinib
Drug: Sirolimus
Drug: Sorafenib
Drug: Sunitinib
Drug: Trametinib
Biological: Trastuzumab Emtansine
Drug: Tretinoin
Drug: Vemurafenib
Drug: Venetoclax
Drug: Vismodegib
Drug: Vorinostat
First Posted Date
2019-03-18
Last Posted Date
2024-03-04
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT03878524
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma

First Posted Date
2018-11-27
Last Posted Date
2021-04-28
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
63
Registration Number
NCT03754179
Locations
🇧🇪

UZ Brussel, Jette, Brabant, Belgium

Dabrafenib + Trametinib + PDR001 In Colorectal Cancer

First Posted Date
2018-09-12
Last Posted Date
2022-06-27
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
25
Registration Number
NCT03668431
Locations
🇺🇸

Dana Farber Cancer Institite, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hosital Cancer Center, Boston, Massachusetts, United States

Melanoma Metastasized to the Brain and Steroids

First Posted Date
2018-06-20
Last Posted Date
2023-07-13
Lead Sponsor
Inge Marie Svane
Target Recruit Count
80
Registration Number
NCT03563729
Locations
🇩🇰

Herlev Universityhospital, Herlev, Hovedstaden, Denmark

🇩🇰

Aarhus Universityhospital, Aarhus, Midt, Denmark

🇩🇰

Odense Universityhospital, Odense, Syd, Denmark

Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK

First Posted Date
2018-06-12
Last Posted Date
2018-06-12
Lead Sponsor
Poitiers University Hospital
Target Recruit Count
20
Registration Number
NCT03553329
Locations
🇫🇷

CHU DE Poitiers, Poitiers, France

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Phase 3
Completed
Conditions
Malignant Melanoma
Interventions
Drug: Dabrafenib
Drug: Trametinib
First Posted Date
2018-06-11
Last Posted Date
2024-06-12
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
552
Registration Number
NCT03551626
Locations
🇬🇧

Novartis Investigative Site, Southampton, United Kingdom

MCS110 With BRAF/MEK Inhibition in Patients With Melanoma

Phase 1
Completed
Conditions
Melanoma
Interventions
Drug: MCS110
Drug: Dabrafenib
Drug: Trametinib
First Posted Date
2018-03-07
Last Posted Date
2024-07-31
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
6
Registration Number
NCT03455764
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

A Study of APR-246 in Combination With Dabrafenib in Resistant Patients With BRAF V600 Mutant Melanoma

Phase 1
Terminated
Conditions
Melanoma
Interventions
Drug: APR-246
Drug: Dabrafenib
First Posted Date
2018-01-05
Last Posted Date
2019-07-31
Lead Sponsor
Aprea Therapeutics
Target Recruit Count
3
Registration Number
NCT03391050
Locations
🇧🇪

Institut Jules Bordet, Bruxelles, Belgium

🇧🇪

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

🇧🇪

CHU UCL Namur - site Sainte-Elisabeth, Namur, Belgium

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