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

Molecular Profiling of Advanced Soft-tissue Sarcomas

Phase 3

Active, not recruiting

Conditions: Soft Tissue Sarcoma

Interventions: Other: Next Generation sequencing exome
Drug: Nilotinib
Drug: Ceritinib
Drug: Capmatinib
Drug: Lapatinib
Drug: Trametinib
Combination Product: Trametinib and Dabrafenib
Combination Product: Olaparib and Durvalumab
Drug: Palbociclib
Drug: Glasdegib
Drug: TAS-120

First Posted Date: 2018-12-21

Last Posted Date: 2025-01-28

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Target Recruit Count: 603

Registration Number: NCT03784014

Locations: 🇫🇷
Centre Oscar Lambret, Lille, France
🇫🇷
IUCT Oncopôle, Toulouse, France
🇫🇷
Institut de Cancérologie de Montpellier, Montpellier, France

and more 16 locations

Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma

Phase 1

Conditions: Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib
Drug: Hydroxychloroquine

First Posted Date: 2018-11-27

Last Posted Date: 2021-04-28

Lead Sponsor: Universitair Ziekenhuis Brussel

Target Recruit Count: 63

Registration Number: NCT03754179

Locations: 🇧🇪
UZ Brussel, Jette, Brabant, Belgium

Treatment of NF1-related Plexiform Neurofibroma With Trametinib

Phase 2

Active, not recruiting

Conditions: Child
Neurofibroma, Plexiform
Neurofibromatosis 1

Interventions: Drug: Trametinib

First Posted Date: 2018-11-14

Last Posted Date: 2024-04-11

Lead Sponsor: Region Skane

Target Recruit Count: 15

Registration Number: NCT03741101

Locations: 🇸🇪
Skåne University Hospital, Lund, Sweden

Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

Phase 1

Completed

Conditions: Colorectal Cancer
Advanced Cancer
Metastatic Cancer

Interventions: Drug: HDM201
Drug: Trametinib

First Posted Date: 2018-10-22

Last Posted Date: 2023-09-13

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 12

Registration Number: NCT03714958

Locations: 🇫🇷
Centre Leon Berard, Lyon, France

Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Non Small Cell Lung Cancer
KRAS Gene Mutation

Interventions: Drug: Trametinib 2 mg
Drug: Trametinib 0.5 mg
Drug: Trametinib 1 MG
Drug: Trametinib 1.5 MG
Drug: Ponatinib 15 MG
Drug: Ponatinib 30 MG

First Posted Date: 2018-10-15

Last Posted Date: 2025-05-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 12

Registration Number: NCT03704688

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity), Commack, New York, United States

and more 4 locations

Dabrafenib + Trametinib + PDR001 In Colorectal Cancer

Phase 2

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Dabrafenib
Drug: Trametinib
Drug: PDR001

First Posted Date: 2018-09-12

Last Posted Date: 2022-06-27

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 25

Registration Number: NCT03668431

Locations: 🇺🇸
Dana Farber Cancer Institite, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hosital Cancer Center, Boston, Massachusetts, United States

Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas

Phase 1

Recruiting

Conditions: Meningioma

Interventions: Drug: Trametinib
Drug: Alpelisib
Biological: Blood sample
Device: MRI

First Posted Date: 2018-08-15

Last Posted Date: 2024-08-06

Lead Sponsor: Assistance Publique Hopitaux De Marseille

Target Recruit Count: 25

Registration Number: NCT03631953

Locations: 🇫🇷
Assistance Publique Hôpitaux de Marseille, Marseille, France

Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma

Phase 1

Terminated

Conditions: Melanoma

Interventions: Drug: Trametinib daily Until PD
Drug: CDX-3379 (ERBB3 antibody)

First Posted Date: 2018-07-09

Last Posted Date: 2020-05-20

Lead Sponsor: NYU Langone Health

Target Recruit Count: 3

Registration Number: NCT03580382

Locations: 🇺🇸
New York University School of Medicine, New York, New York, United States
🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Melanoma Metastasized to the Brain and Steroids

Phase 2

Recruiting

Conditions: Malignant Melanoma

Interventions: Drug: Ipilimumab Injection [Yervoy]
Drug: Pembrolizumab Injection [Keytruda]
Drug: Nivolumab Injection [Opdivo]
Drug: Encorafenib
Drug: Binimetinib
Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2018-06-20

Last Posted Date: 2023-07-13

Lead Sponsor: Inge Marie Svane

Target Recruit Count: 80

Registration Number: NCT03563729

Locations: 🇩🇰
Herlev Universityhospital, Herlev, Hovedstaden, Denmark
🇩🇰
Aarhus Universityhospital, Aarhus, Midt, Denmark
🇩🇰
Odense Universityhospital, Odense, Syd, Denmark

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Phase 3

Completed

Conditions: Malignant Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2018-06-11

Last Posted Date: 2025-04-29

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 552

Registration Number: NCT03551626

Locations: 🇬🇧
Novartis Investigative Site, Southampton, United Kingdom

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy