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
- Associated Therapies
- -
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
- Interventions
- First Posted Date
- 2017-02-27
- Last Posted Date
- 2024-06-26
- 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
- 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
- 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
A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma
- Conditions
- Interventions
- First Posted Date
- 2016-11-28
- Last Posted Date
- 2024-05-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 241
- Registration Number
- NCT02974725
- Locations
- 🇸🇪
Novartis Investigative Site, Stockholm, Sweden
🇺🇸Uni of TX MD Anderson Cancer Cntr, Houston, Texas, United States
🇺🇸Sarah Cannon Research Institute Tennessee Oncology, Nashville, Tennessee, United States
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
- Conditions
- Interventions
- First Posted Date
- 2016-11-18
- Last Posted Date
- 2024-12-03
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 573
- Registration Number
- NCT02967692
- Locations
- 🇺🇸
California Cancer Associates for Research and Excellence, Encinitas, California, United States
🇺🇸UC Irvine Medical Center, Orange, California, United States
🇺🇸Stanford Cancer Center, Stanford, California, United States
Pharmacokinetics of Single and Repeat Oral Doses of Trametinib in Chinese Subjects With Solid Tumours
- First Posted Date
- 2016-10-20
- Last Posted Date
- 2018-09-14
- Lead Sponsor
- GlaxoSmithKline
- Registration Number
- NCT02939846
The Drug Rediscovery Protocol (DRUP Trial)
- Conditions
- Interventions
- Drug: PanitumumabDrug: OlaparibDrug: CrizotinibDrug: ErlotinibDrug: AlectinibDrug: Ipilimumab and nivolumabDrug: SunitinibDrug: Trastuzumab and Pertuzumab (combination treatment)Drug: Vemurafenib and Cobimetinib (combination treatment)Drug: NivolumabDrug: Dabrafenib and trametinibDrug: SelpercatinibDrug: TepotinibDrug: AbemaciclibDrug: ErdafitinibDrug: Atezolizumab and BevacizumabDrug: DacomitinibDrug: DabrafenibDrug: NilotinibDrug: TrametinibDrug: VismodegibDrug: RegorafenibDrug: AfatinibDrug: RibociclibDrug: LenvatinibDrug: PembrolizumabDrug: DurvalumabDrug: RucaparibDrug: AxitinibDrug: PalbociclibDrug: CabozantinibDrug: EntrectinibDrug: TalazoparibDrug: LorlatinibDrug: AlpelisibDrug: NiraparibDrug: Pemigatinib
- First Posted Date
- 2016-10-05
- Last Posted Date
- 2024-01-24
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 1550
- Registration Number
- NCT02925234
- Locations
- 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱Amsterdam UMC, locatie AMC, Amsterdam, Netherlands
A Clinical Trial of Patients With Melanoma
- Conditions
- Interventions
- First Posted Date
- 2016-09-27
- Last Posted Date
- 2018-05-15
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Registration Number
- NCT02915666
- Locations
- 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma
- Conditions
- Interventions
- First Posted Date
- 2016-09-22
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 52
- Registration Number
- NCT02910700
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Trametinib in Treating Patients With Progressive Metastatic Hormone-Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-08-26
- Last Posted Date
- 2023-05-01
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Target Recruit Count
- 14
- Registration Number
- NCT02881242
- Locations
- 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Drug Development Updates
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