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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The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs
- Conditions
- Interventions
- First Posted Date
- 2021-12-16
- Last Posted Date
- 2024-07-15
- Lead Sponsor
- Helsinki University Central Hospital
- Target Recruit Count
- 250
- Registration Number
- NCT05159245
- Locations
- 🇫🇮
Turku University Hospital Cancer Centre, Turku, Varsinais-Suomi, Finland
🇫🇮Kuopio University Hospital, Kuopio, Finland
🇫🇮Oulu University Hospital OYS Cancer Center, Oulu, Finland
Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
- First Posted Date
- 2021-07-14
- Last Posted Date
- 2024-01-05
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 84
- Registration Number
- NCT04961619
- Locations
- 🇹🇷
Novartis Investigative Site, Kecioren Ankara, Turkey
Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer
- Conditions
- Interventions
- First Posted Date
- 2021-06-25
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 153
- Registration Number
- NCT04940052
- Locations
- 🇺🇸
Northwestern University Med School, Chicago, Illinois, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇻🇳Novartis Investigative Site, Hanoi, Vietnam
Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma
- Conditions
- Interventions
- First Posted Date
- 2021-05-26
- Last Posted Date
- 2024-07-01
- Lead Sponsor
- Ruta Arays
- Target Recruit Count
- 15
- Registration Number
- NCT04903119
- Locations
- 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸St. Luke's University Health Network, Easton, Pennsylvania, United States
🇺🇸Markey Cancer Center, Lexington, Kentucky, United States
Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
- Conditions
- Interventions
- First Posted Date
- 2021-03-17
- Last Posted Date
- 2023-05-10
- Lead Sponsor
- Peter MacCallum Cancer Centre, Australia
- Target Recruit Count
- 3
- Registration Number
- NCT04801966
- Locations
- 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer
- Conditions
- Interventions
- First Posted Date
- 2021-02-04
- Last Posted Date
- 2024-03-25
- Lead Sponsor
- Saint Petersburg State University, Russia
- Registration Number
- NCT04739566
- Locations
- 🇷🇺
Saint-Petersburg State University (SPSU) N.I.Pirogov Clinic of High Medical Technologies, Saint Petersburg, Russian Federation
Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer
- First Posted Date
- 2020-12-19
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT04675710
- Locations
- 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States
🇺🇸M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸Stanford School of Medicine, Stanford, California, United States
Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
- First Posted Date
- 2020-12-14
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 80
- Registration Number
- NCT04666272
- Locations
- 🇨🇳
Novartis Investigative Site, Wuhan, China
Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
- First Posted Date
- 2020-09-10
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT04544202
PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer
- First Posted Date
- 2020-09-10
- Last Posted Date
- 2024-11-13
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.