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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Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion
- Conditions
- Interventions
- Drug: Target GeneDrug: Olaparib tabletDrug: Temozolomide capsuleDrug: AnlotinibDrug: Trametinib tabletDrug: DabrafenibDrug: Vebreltinib Enteric CapsulesDrug: Alpelisib PillDrug: Sacituzumab Govitecan-Hziy 180 MGDrug: Lenvatinib CapsulesDrug: Pazopanib PillDrug: Palbociclib PillDrug: ChidamideDrug: PD-1/PD-L1/PD-1&CTLA4 inhibitor
- First Posted Date
- 2024-12-18
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Tianjin Medical University Second Hospital
- Target Recruit Count
- 300
- Registration Number
- NCT06739395
- Locations
- 🇨🇳
Tianjin Medical Unversity Second Hospital, Tianjin, Tianjin, China
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
- Conditions
- Interventions
- First Posted Date
- 2024-10-22
- Last Posted Date
- 2024-10-22
- Target Recruit Count
- 12
- Registration Number
- NCT06653517
- Locations
- 🇨🇳
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-08-01
- Last Posted Date
- 2024-08-09
- Target Recruit Count
- 80
- Registration Number
- NCT06532149
- Locations
- 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy
Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer
- First Posted Date
- 2024-06-26
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- Target Recruit Count
- 264
- Registration Number
- NCT06475989
- Locations
- 🇺🇸
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
🇺🇸Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
🇺🇸Kootenai Clinic Cancer Services - Sandpoint, Sandpoint, Idaho, United States
Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma
- First Posted Date
- 2024-02-20
- Last Posted Date
- 2024-02-20
- Lead Sponsor
- Shandong University
- Target Recruit Count
- 10
- Registration Number
- NCT06264778
Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations
- First Posted Date
- 2023-05-25
- Last Posted Date
- 2023-11-30
- Lead Sponsor
- Se Jun Park
- Target Recruit Count
- 30
- Registration Number
- NCT05876806
- Locations
- 🇰🇷
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea, Republic of
E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma
- Conditions
- Interventions
- First Posted Date
- 2022-05-24
- Last Posted Date
- 2024-03-29
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 18
- Registration Number
- NCT05388877
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
🇺🇸Mayo Clinic in Florida, Jacksonville, Florida, United States
"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"
- First Posted Date
- 2022-03-29
- Last Posted Date
- 2023-09-14
- Lead Sponsor
- Fondazione Melanoma Onlus
- Registration Number
- NCT05299580
- Locations
- 🇮🇹
National Institute of Cancer, Bari, Italy
🇮🇹IRCCS San Martino - IST, Genova, Italy
🇮🇹Azienda Ospedaliera Universitaria di Modena, Modena, Italy
Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US
- Conditions
- Interventions
- First Posted Date
- 2022-03-02
- Last Posted Date
- 2024-05-14
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 1
- Registration Number
- NCT05260684
- Locations
- 🇺🇸
Pfizer Investigational Site, New York, New York, United States
pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
- Conditions
- Interventions
- First Posted Date
- 2021-12-28
- Last Posted Date
- 2022-06-01
- Lead Sponsor
- MelanomaPRO, Russia
- Target Recruit Count
- 500
- Registration Number
- NCT05171374
- Locations
- 🇷🇺
Republican Clinical Oncology Center of Chuvashia, Cheboksary, Chuvash Republic,, Russian Federation
🇷🇺GBUZ Yuzhno-Sakhalinsk oncologic dispensary, Yuzhno-Sakhalinsk, Russian Federation
🇷🇺Irkutsk Regional Oncological Dispensary, Irkutsk, Irkutsk Region, Russian Federation
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.