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

Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea

Phase 1

Completed

Conditions: Rosacea, Erythematotelangiectatic

Interventions: Drug: Trametinib

First Posted Date: 2022-11-15

Last Posted Date: 2023-05-30

Lead Sponsor: Albany Research Institute, Inc.

Target Recruit Count: 12

Registration Number: NCT05616923

Locations: 🇺🇸
Samuel S. Stratton VA Medical Center, Albany, New York, United States

PaTcH Study: A Phase 2 Study of Trametinib and Hydroxychloroquine in Patients With Metastatic Refractory Pancreatic Cancer

Phase 2

Recruiting

Conditions: Pancreatic Cancer

Interventions: Drug: Trametinib
Drug: Hydroxychloroquine

First Posted Date: 2022-08-26

Last Posted Date: 2023-06-18

Lead Sponsor: Cancer Trials Ireland

Target Recruit Count: 22

Registration Number: NCT05518110

Locations: 🇮🇪
Mater Misericordiae University Hospital, Dublin, Ireland
🇮🇪
St Vincent's University Hospital, Dublin, Ireland

Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1

Active, not recruiting

Conditions: Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Trametinib
Drug: Ruxolitinib
Drug: Retifanlimab

First Posted Date: 2022-07-01

Last Posted Date: 2025-03-03

Lead Sponsor: Peter Hosein, MD

Target Recruit Count: 35

Registration Number: NCT05440942

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation

Phase 1

Terminated

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer

Interventions: Drug: Capmatinib
Drug: Trametinib

First Posted Date: 2022-06-28

Last Posted Date: 2024-06-11

Lead Sponsor: Collin Blakely

Target Recruit Count: 3

Registration Number: NCT05435846

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States

A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Phase 1

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: CC-92480
Drug: Tazemetostat
Drug: BMS-986158
Drug: Trametinib
Drug: Dexamethasone

First Posted Date: 2022-05-12

Last Posted Date: 2025-03-19

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 160

Registration Number: NCT05372354

Locations: 🇺🇸
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
🇨🇦
University of Alberta - Cross Cancer Institute, Edmonton, Alberta, Canada
🇪🇸
ICO - Hospital Germans Trias i Pujol, Barcelona, Spain

and more 14 locations

Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Phase 1

Active, not recruiting

Conditions: Carcinoma, Non-Small Cell Lung
Colorectal Tumors
Neoplasms, Colorectal
KRAS G12C Mutant Solid Tumors
Non-Small Cell Lung Carcinoma
Carcinoma, Non-Small-Cell Lung
Colorectal Carcinoma
Nonsmall Cell Lung Cancer
Colorectal Cancer
Non-Small Cell Lung Cancer

Interventions: Drug: JDQ443
Drug: Ribociclib
Drug: trametinib
Biological: cetuximab

First Posted Date: 2022-05-03

Last Posted Date: 2025-03-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 346

Registration Number: NCT05358249

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
NYU School of Medicine, New York, New York, United States

and more 1 locations

"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"

Phase 2

Withdrawn

Conditions: Melanoma

Interventions: Drug: dabrafenib
Drug: Trametinib

First Posted Date: 2022-03-29

Last Posted Date: 2023-09-14

Lead Sponsor: Fondazione Melanoma Onlus

Registration Number: NCT05299580

Locations: 🇮🇹
National Institute of Cancer, Bari, Italy
🇮🇹
IRCCS San Martino - IST, Genova, Italy
🇮🇹
Azienda Ospedaliera Universitaria di Modena, Modena, Italy

and more 13 locations

XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation

Phase 1

Not yet recruiting

Conditions: Melanoma
Nonsmall Cell Lung Cancer
Cancer
BRAF V600 Mutation
Colorectal Cancer
Thyroid Cancer

Interventions: Drug: XP-102
Drug: Trametinib

First Posted Date: 2022-03-11

Last Posted Date: 2025-04-10

Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Target Recruit Count: 221

Registration Number: NCT05275374

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Completed

Conditions: Melanoma

Interventions: Drug: Encorafenib
Drug: Dabrafenib
Drug: Vemurafenib
Drug: Binimetinib
Drug: Cobimetinib
Drug: Trametinib

First Posted Date: 2022-03-02

Last Posted Date: 2025-03-06

Lead Sponsor: Pfizer

Target Recruit Count: 716

Registration Number: NCT05260684

Locations: 🇺🇸
Pfizer Investigational Site, New York, New York, United States

A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)

Phase 2

Recruiting

Conditions: Thyroid Cancer

Interventions: Drug: Dabrafenib 75 MG
Drug: Trametinib 2 MG

First Posted Date: 2022-01-10

Last Posted Date: 2023-10-31

Lead Sponsor: Olivia Newton-John Cancer Research Institute

Target Recruit Count: 80

Registration Number: NCT05182931

Locations: 🇦🇺
Royal Adelaide Hsopital, Adelaide, South Australia, Australia
🇦🇺
Austin Health, Heidelberg, Victoria, Australia
🇦🇺
Sir Charles Gairdner Hospital, Perth, Western Australia, Australia

and more 6 locations

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