Trametinib
- Generic Name
- Trametinib
- Brand Names
- Mekinist, Spexotras
- Drug Type
- Small Molecule
- Chemical Formula
- C26H23FIN5O4
- CAS Number
- 871700-17-3
- Unique Ingredient Identifier
- 33E86K87QN
- Background
Trametinib is an orally bioavailable mitogen-activated extracellular signal-regulated kinase 1 (MEK1) and MEK2 inhibitor. It was first approved by the FDA in May 2013 for the treatment of melanoma. It was later approved by Health Canada on July 18, 2013 and by the European Commission on June 30, 2014. Trametinib is currently approved to treat a variety of cancers with BRAF mutations, such as non-small cell lung cancer and thyroid cancer, as monotherapy or in combination with dabrafenib, a BRAF inhibitor, for improved therapeutic efficacy. Originally developed by Japan Tobacco, trametinib was initially investigated for treating inflammation, but further studies for this indication were not pursued.
- Indication
Trametinib is indicated as monotherapy for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
It is used in combination with dabrafenib for the:
In the US, BRAF V600E or V600K mutations must be detected by an FDA-approved test. Trametinib is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
- Associated Conditions
- Advanced Non-Small Cell Lung Cancer (NSCLC), Locally Advanced Anaplastic Thyroid Cancer, Low-Grade Glioma, Melanoma, Metastatic Anaplastic Thyroid Cancer, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Stage III Melanoma, Unresectable Melanoma, Unresectable or Metastatic Solid Tumors
Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma
- Conditions
- Metastatic Melanoma
- 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
Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery
- Conditions
- Unresectable Epithelioid HemangioendotheliomaLocally Advanced Epithelioid HemangioendotheliomaMetastatic Epithelioid Hemangioendothelioma
- Interventions
- Other: Questionnaire Administration
- First Posted Date
- 2017-05-10
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 44
- Registration Number
- NCT03148275
- Locations
- 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma
- 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
- Conditions
- BRAF Gene MutationMelanoma
- Interventions
- Drug: Talimogene Laherparepvec 1 Million Pfu/Ml Inj,Susp,1Ml,VilDrug: Talimogene Laherparep 100 Mil Pfu/Ml 1Ml
- 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
Panitumumab With or Without Trametinib in Treating Patients With Stage IV Colorectal Cancer
- Conditions
- MAP2K1 Gene MutationStage IVA Colorectal Cancer AJCC v7KRAS Gene MutationMetastatic Colorectal AdenocarcinomaRefractory Colorectal AdenocarcinomaEGFR NP_005219.2:p.S492RStage IV Colorectal Cancer AJCC v7Stage IVB Colorectal Cancer AJCC v7
- Interventions
- First Posted Date
- 2017-03-22
- Last Posted Date
- 2025-01-15
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 59
- Registration Number
- NCT03087071
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
- First Posted Date
- 2017-03-22
- Last Posted Date
- 2022-12-27
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 9
- Registration Number
- NCT03087448
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸University of California, Davis, Davis, California, United States
Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer
- Conditions
- Anaplastic Thyroid Cancer
- Interventions
- First Posted Date
- 2017-03-21
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 13
- Registration Number
- NCT03085056
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities), Commack, New York, United States
A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib
- Conditions
- Lung CancerRecurrent Lung AdenocarcinomaLung AdenocarcinomaLung Cancer MetastaticLung Cancer Stage IVRecurrent Lung Cancer
- Interventions
- First Posted Date
- 2017-03-10
- Last Posted Date
- 2024-04-02
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 24
- Registration Number
- NCT03076164
- Locations
- 🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation
- Conditions
- Advanced Malignant Solid NeoplasmERBB4 Gene MutationRefractory Malignant Solid NeoplasmERBB3 Gene MutationKRAS Gene MutationERBB2 Gene MutationEGFR Gene MutationERBB2 Gene AmplificationMetastatic Malignant Solid NeoplasmEGFR Gene Amplification
- Interventions
- First Posted Date
- 2017-02-27
- Last Posted Date
- 2025-02-10
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 93
- Registration Number
- NCT03065387
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma
- First Posted Date
- 2017-01-20
- Last Posted Date
- 2025-01-23
- 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
Drug Development Updates
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