Trametinib

Generic Name: Trametinib

Brand Names: Mekinist, Spexotras

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₃FIN_₅O_₄

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

Clinical Trials

Pediatric Low Grade Glioma - MEKinhibitor TRIal vs Chemotherapy

Phase 2

Recruiting

Conditions: Grade 1 Glioma
Mixed Glio-neuronal Tumors
Pleomorphic Xanthoastrocytoma

Interventions: Drug: Vinblastine
Drug: Trametinib

First Posted Date: 2022-01-06

Last Posted Date: 2024-08-29

Lead Sponsor: University Hospital, Strasbourg, France

Target Recruit Count: 134

Registration Number: NCT05180825

Locations: 🇫🇷
Chu de Besancon, Besancon, France
🇫🇷
CHU de REIMS, Reims, France
🇫🇷
Groupe Hospitalier Pellegrin, Bordeaux, France

and more 22 locations

pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE

Recruiting

Conditions: Melanoma Stage III
Melanoma Stage IV
Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib

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

and more 12 locations

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Phase 2

Recruiting

Conditions: Advanced Cancer
Solid Tumor
Haematological Malignancy

Interventions: Drug: Cobimetinib
Drug: Trastuzumab+Pertuzumab
Drug: Trametinib
Drug: Dabrafenib+Trametinib
Drug: Abemaciclib
Drug: Tepotinib
Drug: Dabrafenib
Drug: Pemigatinib
Drug: Regorafenib
Drug: Alectinib
Drug: Vismodegib
Drug: Entrectinib
Drug: Atezolizumab
Drug: Vemurafenib
Drug: Apalutamide

First Posted Date: 2021-12-16

Last Posted Date: 2024-07-15

Lead Sponsor: Helsinki University Central Hospital

Target Recruit Count: 250

Registration Number: NCT05159245

Locations: 🇫🇮
Turku University Hospital Cancer Centre, Turku, Varsinais-Suomi, Finland
🇫🇮
Kuopio University Hospital, Kuopio, Finland
🇫🇮
Oulu University Hospital OYS Cancer Center, Oulu, Finland

and more 2 locations

A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors

Phase 1

Terminated

Conditions: KRAS Mutation-Related Tumors
Advanced Solid Tumor
Metastatic Solid Tumor

Interventions: Drug: TPX-0005
Drug: Trametinib

First Posted Date: 2021-10-08

Last Posted Date: 2024-04-02

Lead Sponsor: Turning Point Therapeutics, Inc.

Target Recruit Count: 9

Registration Number: NCT05071183

Locations: 🇺🇸
Local Institution - 2107, Houston, Texas, United States
🇺🇸
Local Institution - 2102, Virginia Beach, Virginia, United States
🇺🇸
Local Institution - 2101, California City, California, United States

and more 3 locations

Trametinib Plus Anlotinib in Non-G12C KRAS-Mutant NSCLC Patients

Phase 1

Completed

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Trametinib
Drug: Anlotinib

First Posted Date: 2021-07-19

Last Posted Date: 2024-04-23

Lead Sponsor: Shanghai Chest Hospital

Target Recruit Count: 33

Registration Number: NCT04967079

Locations: 🇨🇳
Shanghai Chest Hospital, Shanghai, Shanghai, China

Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

Completed

Conditions: Melanoma

Interventions: Drug: dabrafenib
Drug: trametinib

First Posted Date: 2021-07-14

Last Posted Date: 2025-01-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 39

Registration Number: NCT04961619

Locations: 🇹🇷
Novartis Investigative Site, Kecioren Ankara, Turkey

Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients

Phase 2

Recruiting

Conditions: Histiocytosis

Interventions: Drug: Trametinib

First Posted Date: 2021-06-29

Last Posted Date: 2025-04-13

Lead Sponsor: Anna Raciborska

Target Recruit Count: 12

Registration Number: NCT04943224

Locations: 🇵🇱
Mother and Child Institute, Warsaw, Mazovian, Poland

Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer

Phase 3

Active, not recruiting

Conditions: Differentiated Thyroid Cancer

Interventions: Drug: Dabrafenib
Drug: Trametinib placebo
Drug: Dabrafenib placebo
Drug: Trametinib

First Posted Date: 2021-06-25

Last Posted Date: 2025-05-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 153

Registration Number: NCT04940052

Locations: 🇺🇸
Northwestern University Med School, Chicago, Illinois, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇻🇳
Novartis Investigative Site, Hanoi, Vietnam

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Phase 1

Recruiting

Conditions: Metastatic Melanoma
BRAF Gene Mutation

Interventions: Drug: Nilotinib 100mg
Drug: Nilotinib 200mg
Drug: Nilotinib 300mg
Drug: Nilotinib 400mg
Drug: Dabrafenib
Drug: Trametinib
Drug: Encorafenib
Drug: Binimetinib

First Posted Date: 2021-05-26

Last Posted Date: 2025-03-07

Lead Sponsor: Ruta Arays

Target Recruit Count: 30

Registration Number: NCT04903119

Locations: 🇺🇸
Markey Cancer Center, Lexington, Kentucky, United States
🇺🇸
St. Luke's University Health Network, Easton, Pennsylvania, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

A Phase 1/2 Study of Inlexisertib (DCC-3116) in Patients With RAS/MAPK Pathway Mutant Solid Tumors

Phase 1

Recruiting

Conditions: Non-Small Cell Lung Cancer
Advanced Solid Tumor
Metastatic Solid Tumor

Interventions: Drug: Inlexisertib
Drug: Trametinib
Drug: Sotorasib
Drug: Binimetinib

First Posted Date: 2021-05-19

Last Posted Date: 2025-05-06

Lead Sponsor: Deciphera Pharmaceuticals, LLC

Target Recruit Count: 144

Registration Number: NCT04892017

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Washington University Siteman Cancer Center, Saint Louis, Missouri, United States
🇺🇸
Rutgers Cancer Institute, New Brunswick, New Jersey, United States

and more 6 locations

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