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
- -
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
- First Posted Date
- 2014-04-28
- Last Posted Date
- 2021-07-14
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 139
- Registration Number
- NCT02124772
- Locations
- 🇬🇧
Novartis Investigative Site, London, United Kingdom
A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma
- Conditions
- Interventions
- First Posted Date
- 2014-04-10
- Last Posted Date
- 2021-03-26
- Lead Sponsor
- Kartos Therapeutics, Inc.
- Target Recruit Count
- 31
- Registration Number
- NCT02110355
- Locations
- 🇦🇺
Research Site, Melbourne, Victoria, Australia
Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
- Conditions
- Metastatic Malignant Solid NeoplasmStage III Cutaneous Melanoma AJCC v7BRAF V600E Mutation PresentStage IV Cutaneous Melanoma AJCC v6 and v7BRAF V600K Mutation PresentStage IIIB Cutaneous Melanoma AJCC v7Unresectable Solid NeoplasmMetastatic MelanomaStage IIIA Cutaneous Melanoma AJCC v7Stage IIIC Cutaneous Melanoma AJCC v7
- Interventions
- First Posted Date
- 2014-03-27
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 22
- Registration Number
- NCT02097225
- Locations
- 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma
- First Posted Date
- 2014-03-11
- Last Posted Date
- 2022-02-01
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 77
- Registration Number
- NCT02083354
- Locations
- 🇹🇭
Novartis Investigative Site, Songkla, Thailand
Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study
- Conditions
- Interventions
- 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
- Conditions
- Interventions
- 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
- 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
- Conditions
- Interventions
- 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
- Conditions
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyDrug: DabrafenibProcedure: EchocardiographyOther: Laboratory Biomarker AnalysisProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanOther: Pharmacological StudyBiological: NavitoclaxDrug: Trametinib
- First Posted Date
- 2013-11-21
- Last Posted Date
- 2024-11-15
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 75
- Registration Number
- NCT01989585
- Locations
- 🇺🇸
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
🇺🇸UM Sylvester Comprehensive Cancer Center at Kendall, Miami, Florida, United States
Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma
- First Posted Date
- 2013-10-30
- Last Posted Date
- 2023-08-30
- Lead Sponsor
- Melanoma Institute Australia
- Target Recruit Count
- 35
- Registration Number
- NCT01972347
- Locations
- 🇦🇺
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.