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

Imatinib and Trametinib for KRAS-mutated Solid Tumor

Phase 1

Recruiting

Conditions: Solid Tumor Cancer

Interventions: Drug: Imatinib
Drug: Trametinib

First Posted Date: 2025-05-08

Last Posted Date: 2025-05-08

Lead Sponsor: China Medical University Hospital

Target Recruit Count: 10

Registration Number: NCT06962254

Locations: 🇨🇳
China Medical University Hospital, Taichung, Taiwan

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: VVD-159642
Drug: Sotorasib
Drug: Trametinib

First Posted Date: 2025-02-03

Last Posted Date: 2025-05-18

Lead Sponsor: Vividion Therapeutics, Inc.

Target Recruit Count: 220

Registration Number: NCT06804824

Locations: 🇺🇸
START Mid West, Grand Rapids, Michigan, United States
🇺🇸
START San Antonio, San Antonio, Texas, United States
🇺🇸
START Mountain, Ogden, Utah, United States

and more 5 locations

Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

Phase 2

Recruiting

Conditions: Solid Tumor
Precision Medicine

Interventions: Drug: Olaparib tablet
Drug: Target Gene
Drug: Temozolomide capsule
Drug: Anlotinib
Drug: Trametinib tablet
Drug: Dabrafenib
Drug: Vebreltinib Enteric Capsules
Drug: Alpelisib Pill
Drug: Sacituzumab Govitecan-Hziy 180 MG
Drug: Lenvatinib Capsules
Drug: Pazopanib Pill
Drug: Palbociclib Pill
Drug: Chidamide
Drug: PD-1/PD-L1/PD-1&CTLA4 inhibitor

First Posted Date: 2024-12-18

Last Posted Date: 2024-12-18

Lead Sponsor: Tianjin Medical University Second Hospital

Target Recruit Count: 300

Registration Number: NCT06739395

Locations: 🇨🇳
Tianjin Medical Unversity Second Hospital, Tianjin, Tianjin, China

MAPK Inhibition Combined with Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas

Phase 1

Recruiting

Conditions: Low Grade Glioma
High Grade Glioma

Interventions: Drug: Trametinib and Nivolumab
Drug: Dabrafenib, trametinib, nivolumab

First Posted Date: 2024-12-02

Last Posted Date: 2025-02-12

Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Target Recruit Count: 27

Registration Number: NCT06712875

Locations: 🇺🇸
Children's National Hospital, Washington DC, District of Columbia, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Phase 2

Recruiting

Conditions: Ameloblastoma
BRAF V600E Mutation Positive

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2024-10-22

Last Posted Date: 2024-10-22

Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Target Recruit Count: 12

Registration Number: NCT06653517

Locations: 🇨🇳
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Targeted Approach to Langerhans Cell Histiocytosis (LCH) Using MEK Inhibitor, Trametinib

Phase 2

Recruiting

Conditions: Langerhans Cell Histiocytosis

Interventions: Drug: Trametinib

First Posted Date: 2024-09-03

Last Posted Date: 2024-12-12

Lead Sponsor: Cook Children's Health Care System

Target Recruit Count: 75

Registration Number: NCT06582745

Locations: 🇺🇸
Cook Children's Health Care System, Fort Worth, Texas, United States

MEK Inhibitors for the Treatment of Hypertrophic Cardiomyopathy in Patients With RASopathies

Phase 2

Recruiting

Conditions: Cardiomegaly
Noonan Syndrome

Interventions: Drug: Trametinib tablet
Drug: Standard therapy

First Posted Date: 2024-08-15

Last Posted Date: 2024-08-15

Lead Sponsor: Medical University of Warsaw

Target Recruit Count: 40

Registration Number: NCT06555237

Locations: 🇵🇱
Department of Paediatrics, The Medical University of Warsaw, Poland, Warsaw, Poland

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting

Conditions: Hypogonadism, Male
NSCLC Stage IV
Sex Disorder
Erectile Dysfunction

Interventions: Drug: Alectinib
Drug: Osimertinib
Drug: Pembrolizumab
Drug: Cemiplimab
Drug: Brigatinib
Drug: Sotorasib
Drug: Lorlatinib 100 mg
Drug: Dabrafenib
Drug: Nivolumab
Drug: Trametinib
Drug: Carboplatin
Drug: Pemetrexed
Drug: Selpercatinib
Drug: Paclitaxel

First Posted Date: 2024-08-01

Last Posted Date: 2024-08-09

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 80

Registration Number: NCT06532149

Locations: 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy

Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

Phase 3

Recruiting

Conditions: Refractory Differentiated Thyroid Gland Carcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Cabozantinib
Drug: Dabrafenib
Procedure: Magnetic Resonance Imaging
Other: Questionnaire Administration
Drug: Trametinib

First Posted Date: 2024-06-26

Last Posted Date: 2024-11-18

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 264

Registration Number: NCT06475989

Locations: 🇺🇸
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
🇺🇸
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
🇺🇸
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint, Idaho, United States

and more 108 locations

Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

Phase 1

Not yet recruiting

Conditions: Advanced Lung Cancer
Refractory Tumor
KRAS Mutation-Related Tumors

Interventions: Drug: Trametinib
Drug: Anlotinib
Drug: Tislelizumab

First Posted Date: 2024-06-13

Last Posted Date: 2024-06-13

Lead Sponsor: Shanghai Chest Hospital

Target Recruit Count: 60

Registration Number: NCT06456138

Locations: 🇨🇳
Shanghai Chest Hospital, Shanghai, China

Drug Development Updates

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