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
- -
Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery
- Conditions
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyDrug: DabrafenibDrug: Dabrafenib MesylateProcedure: EchocardiographyDrug: LapatinibDrug: Lapatinib DitosylateProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanProcedure: Positron Emission Tomography
- First Posted Date
- 2013-09-20
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 21
- Registration Number
- NCT01947023
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery
- Conditions
- Interventions
- First Posted Date
- 2013-09-12
- Last Posted Date
- 2022-03-10
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 15
- Registration Number
- NCT01940809
- Locations
- 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
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)
- 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
- 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
Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma
- Conditions
- Interventions
- 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)
- Conditions
- Interventions
- 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
Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer
- Conditions
- Interventions
- 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
Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets
- Conditions
- Interventions
- 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
- Conditions
- Interventions
- 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
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.