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.
...
- 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:
...
- 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
- -
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
- 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
- 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
- Conditions
- Interventions
- First Posted Date
- 2020-07-01
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 40
- Registration Number
- NCT04452877
- Locations
- 🇨🇳
Novartis Investigative Site, Shanghai, China
JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations
- 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
Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma
- 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
- Conditions
- Interventions
- 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
Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer
- Conditions
- Interventions
- First Posted Date
- 2020-01-23
- Last Posted Date
- 2024-12-02
- 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
A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration
- First Posted Date
- 2019-12-17
- Last Posted Date
- 2024-04-05
- Lead Sponsor
- Pediatric Brain Tumor Consortium
- Target Recruit Count
- 75
- Registration Number
- NCT04201457
- Locations
- 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸Children's Healthcare of Atlanta, Atlanta, Georgia, United States
🇺🇸Children's Hospital Colorado, Aurora, Colorado, United States
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors.
- Conditions
- Interventions
- First Posted Date
- 2019-10-04
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- Centre Leon Berard
- Target Recruit Count
- 455
- Registration Number
- NCT04116541
- Locations
- 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷Centre Léon Bérard, Lyon, France
🇫🇷Institut Paoli Calmettes, Marseille, France
TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma
- Conditions
- Interventions
- First Posted Date
- 2019-08-16
- Last Posted Date
- 2023-09-26
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Target Recruit Count
- 45
- Registration Number
- NCT04059224
- Locations
- 🇧🇪
Universitair Ziekenhuis Brussel, Jette, Brussels, Belgium
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.