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:
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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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Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-11-24
Last Posted Date
2020-12-08
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
79
Registration Number
NCT03352947
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

Dabrafenib and/or Trametinib Rollover Study

First Posted Date
2017-11-13
Last Posted Date
2024-10-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
100
Registration Number
NCT03340506
Locations
🇺🇸

Honor Health Research Institute, Scottsdale, Arizona, United States

🇺🇸

National Institute Of Health, Bethesda, Maryland, United States

🇺🇸

James Cancer Hospital and Solove Research Institute Ohio State, Columbus, Ohio, United States

and more 2 locations

INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2017-09-05
Last Posted Date
2023-09-22
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
1
Registration Number
NCT03272464
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Efficacy and Safety of Precision Therapy in Refractory Tumor

First Posted Date
2017-08-03
Last Posted Date
2022-03-04
Lead Sponsor
Baodong Qin
Target Recruit Count
300
Registration Number
NCT03239015
Locations
🇨🇳

Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-05-11
Last Posted Date
2024-03-21
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
16
Registration Number
NCT03149029
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Massachusetts general Hospital, Boston, Massachusetts, United States

A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2017-03-27
Last Posted Date
2024-04-16
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
30
Registration Number
NCT03091257
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Karmanos Cancer Institute, Detroit, Michigan, United States

Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma

First Posted Date
2017-03-23
Last Posted Date
2020-10-12
Lead Sponsor
West Cancer Center
Target Recruit Count
4
Registration Number
NCT03088176
Locations
🇺🇸

West Cancer Center, Germantown, Tennessee, United States

Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-01-20
Last Posted Date
2024-02-09
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
18
Registration Number
NCT03026517
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-11-28
Last Posted Date
2021-08-20
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
6
Registration Number
NCT02974803
Locations
🇨🇦

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

🇨🇦

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

🇨🇦

Odette Cancer Centre, Toronto, Ontario, Canada

and more 3 locations
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