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
TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma
- Conditions
- Stage III MelanomaStage IV Melanoma
- Interventions
- First Posted Date
- 2019-08-16
- Last Posted Date
- 2023-09-26
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Target Recruit Count
- 45
- Registration Number
- NCT04059224
- Locations
- 🇧🇪
Universitair Ziekenhuis Brussel, Jette, Brussels, Belgium
MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma
- Conditions
- Metastatic NRAS Melanoma
- Interventions
- First Posted Date
- 2019-06-07
- Last Posted Date
- 2025-05-22
- Lead Sponsor
- Hospices Civils de Lyon
- Target Recruit Count
- 29
- Registration Number
- NCT03979651
- Locations
- 🇫🇷
CHU Estaing, Clermont-Ferrand, Clermont Ferrand, France
🇫🇷Centre Hospitalier Lyon Sud, Lyon, Pierre-Bénite, France
🇫🇷CHU Grenoble Alpes, La Tronche, France
Pediatric Long-Term Follow-up and Rollover Study
- Conditions
- Diffuse AstrocytomaAnaplastic AstrocytomaAstrocytomaOligodendroglioma, ChildhoodAnaplastic OligodendrogliomaGlioblastomaPilocytic AstrocytomaGiant Cell AstrocytomaPleomorphic XanthoastrocytomaAnaplastic Pleomorphic Xanthoastrocytoma
- Interventions
- First Posted Date
- 2019-06-05
- Last Posted Date
- 2025-04-10
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 164
- Registration Number
- NCT03975829
- Locations
- 🇺🇸
Phoenix Children s Hospital, Phoenix, Arizona, United States
🇺🇸Childrens National Hospital, Washington, District of Columbia, United States
🇺🇸Nicklaus Childrens Hospital, Miami, Florida, United States
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
- Conditions
- BRAF NP_004324.2:p.V600EThyroid Gland Anaplastic CarcinomaBRAF V600K Mutation Present
- Interventions
- First Posted Date
- 2019-06-05
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 6
- Registration Number
- NCT03975231
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸Univ of Texas-M.D. Anderson Cancer Center, Houston, Texas, United States
🇺🇸Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma
- Conditions
- Melanoma (Skin)Metastasis SkinMelanoma Stage IIIb-IVM1aTumor SkinBRAF Gene Mutation
- Interventions
- Drug: Talimogene laherparepvec (T-Vec)
- First Posted Date
- 2019-06-03
- Last Posted Date
- 2020-10-19
- Lead Sponsor
- TriHealth Inc.
- Registration Number
- NCT03972046
- Locations
- 🇺🇸
TriHealth Cancer Institute - Kenwood, Cincinnati, Ohio, United States
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
- Conditions
- Anaplastic AstrocytomaAnaplastic Astrocytoma, Not Otherwise SpecifiedAnaplastic GangliogliomaAnaplastic Pleomorphic XanthoastrocytomaGlioblastomaMalignant GliomaWHO Grade 3 GliomaWHO Grade 4 Glioma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Lumbar PunctureProcedure: Magnetic Resonance ImagingRadiation: Radiation Therapy
- First Posted Date
- 2019-04-18
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 58
- Registration Number
- NCT03919071
- Locations
- 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸Banner Children's at Desert, Mesa, Arizona, United States
🇺🇸Phoenix Childrens Hospital, Phoenix, Arizona, United States
Pan Tumor Rollover Study
- Conditions
- Cancer
- Interventions
- Drug: Regorafinib
- First Posted Date
- 2019-04-02
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1500
- Registration Number
- NCT03899155
- Locations
- 🇨🇳
Local Institution - 0245, Harbin, Heilongjiang, China
🇺🇸Local Institution - 0110, Pittsburgh, Pennsylvania, United States
🇮🇹Local Institution - 0327, Modena, Italy
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAnatomic Stage IV Breast Cancer AJCC v8AnemiaAnn Arbor Stage III Hodgkin LymphomaAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage IV Hodgkin LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveCastration-Resistant Prostate Carcinoma
- Interventions
- Biological: BevacizumabProcedure: Biospecimen CollectionBiological: DurvalumabBiological: IpilimumabBiological: NivolumabBiological: PembrolizumabBiological: PertuzumabOther: Quality-of-Life AssessmentBiological: Trastuzumab Emtansine
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 2
- Registration Number
- NCT03878524
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer
- Conditions
- Stage IV Pancreatic CancerMetastatic Pancreatic CarcinomaStage II Pancreatic CancerUnresectable Pancreatic CarcinomaStage IIB Pancreatic CancerStage III Pancreatic CancerStage IIA Pancreatic Cancer
- Interventions
- First Posted Date
- 2019-01-31
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- University of Utah
- Target Recruit Count
- 25
- Registration Number
- NCT03825289
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations
- Conditions
- Erdheim-Chester Disease
- Interventions
- Other: Quality-of-Life AssessmentOther: Questionnaire Administration
- First Posted Date
- 2019-01-07
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Registration Number
- NCT03794297
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Drug Development Updates
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