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
Dabrafenib and Trametinib in Patients With Non-small Cell Lung Cancer Harboring V600E BRAF Mutation
- Conditions
- Lung Cancer MetastaticBRAF V600ECancer
- First Posted Date
- 2018-06-01
- Last Posted Date
- 2018-06-01
- Lead Sponsor
- Asan Medical Center
- Target Recruit Count
- 27
- Registration Number
- NCT03543306
- Locations
- 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of
EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations
- First Posted Date
- 2018-05-04
- Last Posted Date
- 2024-02-15
- Lead Sponsor
- University of Cologne
- Target Recruit Count
- 18
- Registration Number
- NCT03516214
- Locations
- 🇩🇪
University Hospital Dresden, Dresden, Germany
🇩🇪University Hospital of Cologne, Cologne, Germany
🇪🇸Vall d'Hebron University Hospital, Barcelona, Spain
Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma
- Conditions
- MelanomaUnresectable MelanomaAdvanced Melanoma
- Interventions
- First Posted Date
- 2018-04-18
- Last Posted Date
- 2025-05-21
- Target Recruit Count
- 27
- Registration Number
- NCT03501368
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
MCS110 With BRAF/MEK Inhibition in Patients With Melanoma
- First Posted Date
- 2018-03-07
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 6
- Registration Number
- NCT03455764
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
- Conditions
- Anaplastic AstrocytomaAnaplastic EpendymomaAnaplastic GangliogliomaAnaplastic MeningiomaAnaplastic OligodendrogliomaPleomorphic Xanthoastrocytoma, AnaplasticAtypical Teratoid/Rhabdoid TumorBrain CancerBrain TumorCentral Nervous System Neoplasms
- Interventions
- First Posted Date
- 2018-02-15
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- St. Jude Children's Research Hospital
- Target Recruit Count
- 68
- Registration Number
- NCT03434262
- Locations
- 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer
- Conditions
- Malignant Neoplasms of Digestive OrgansColorectal CancerColon Cancer
- Interventions
- First Posted Date
- 2018-02-09
- Last Posted Date
- 2023-06-15
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 29
- Registration Number
- NCT03428126
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Compassionate Use: Progressive Metastatic Castrate Resistant Prostate Cancer; Monotherapy Treatment With Trametinib
- Conditions
- Progressive Metastatic Castrate Resistant Prostate Cancer
- First Posted Date
- 2017-12-29
- Last Posted Date
- 2019-01-16
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Registration Number
- NCT03386071
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
- Conditions
- Colorectal CancerColorectal NeoplasmColorectal TumorsColorectal Carcinoma
- Interventions
- First Posted Date
- 2017-12-19
- Last Posted Date
- 2025-03-13
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 325
- Registration Number
- NCT03377361
- Locations
- 🇺🇸
Local Institution - 0111, Miami, Florida, United States
🇨🇱Local Institution - 0118, Santiago, Región Metropolitana De Santiago, Chile
🇺🇸Local Institution - 0002, Madison, Wisconsin, United States
Trametinib for Pediatric Neuro-oncology Patients With Refractory Tumor and Activation of the MAPK/ERK Pathway.
- Conditions
- Low-grade GliomaPlexiform NeurofibromaCentral Nervous System Glioma
- Interventions
- First Posted Date
- 2017-12-06
- Last Posted Date
- 2023-11-27
- Lead Sponsor
- St. Justine's Hospital
- Target Recruit Count
- 114
- Registration Number
- NCT03363217
- Locations
- 🇨🇦
Alberta Children's Hospital, Calgary, Alberta, Canada
🇨🇦CHU Sainte-Justine, Montreal, Quebec, Canada
🇨🇦CHU de Québec, Quebec City, Quebec, Canada
Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
- First Posted Date
- 2017-11-24
- Last Posted Date
- 2020-12-08
- Target Recruit Count
- 79
- Registration Number
- NCT03352947
- Locations
- 🇬🇧
Addenbrooke's Hospital, Cambridge, England, United Kingdom
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.