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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
Clinical Trials
Related News

Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

Phase 1
Terminated
Conditions
Amyotrophic Lateral Sclerosis
Interventions
First Posted Date
2020-03-30
Last Posted Date
2023-05-09
Lead Sponsor
Genuv Inc.
Target Recruit Count
23
Registration Number
NCT04326283
Locations
🇰🇷

Inje University Busan Paik Hospital, Busan, Korea, Republic of

🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

and more 2 locations

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

Phase 2
Terminated
Conditions
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Interventions
Procedure: Therapeutic Conventional Surgery
First Posted Date
2020-03-17
Last Posted Date
2024-10-30
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
4
Registration Number
NCT04310397
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Study of Trametinib and Ruxolitinib in Colorectal Cancer and Pancreatic Adenocarcinoma

Phase 1
Recruiting
Conditions
Pancreatic Adenocarcinoma
Colorectal Cancer
Interventions
First Posted Date
2020-03-11
Last Posted Date
2023-10-11
Lead Sponsor
National Cancer Centre, Singapore
Target Recruit Count
48
Registration Number
NCT04303403
Locations
🇸🇬

National Cancer Centre, Singapore, Singapore

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

First Posted Date
2020-03-03
Last Posted Date
2024-11-14
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
122
Registration Number
NCT04294160
Locations
🇺🇸

University of California LA Santa Monica Location, Los Angeles, California, United States

🇺🇸

Massachusetts General Hospital Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Sarah Cannon Research Institute SC, Nashville, Tennessee, United States

and more 2 locations

Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation

Phase 2
Recruiting
Conditions
Arterial Disease
Venous Malformation
Interventions
First Posted Date
2020-02-06
Last Posted Date
2023-06-12
Lead Sponsor
Stanford University
Target Recruit Count
30
Registration Number
NCT04258046
Locations
🇺🇸

Pediatric Dermatology Clinic at Stanford Children's Hospital, Palo Alto, California, United States

Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

Phase 2
Active, not recruiting
Conditions
Thyroid Cancer
BRAF Gene Mutation
Anaplastic Thyroid Cancer
BRAF Mutation-Related Tumors
Interventions
First Posted Date
2020-01-23
Last Posted Date
2025-04-18
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
16
Registration Number
NCT04238624
Locations
🇺🇸

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration

Phase 1
Active, not recruiting
Conditions
Low Grade Glioma of Brain With Neurofibromatosis Type 1
High Grade Glioma (HGG) of the Brain With BRAF Aberration
Low Grade Glioma (LGG) of Brain With BRAF Aberration
Interventions
First Posted Date
2019-12-17
Last Posted Date
2025-02-04
Lead Sponsor
Pediatric Brain Tumor Consortium
Target Recruit Count
57
Registration Number
NCT04201457
Locations
🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States

and more 12 locations

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Phase 1
Recruiting
Conditions
Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Interventions
Drug: IV Chemotherapy (Regimen 1)
Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel
Drug: IV Chemotherapy (Regimen 2)
First Posted Date
2019-12-04
Last Posted Date
2025-03-27
Lead Sponsor
Amgen
Target Recruit Count
1200
Registration Number
NCT04185883
Locations
🇺🇸

Arizona Oncology Associates Professional Corporation, Tucson, Arizona, United States

🇺🇸

City of Hope National Medical Center, Duarte, California, United States

🇺🇸

University of California San Diego Moores Cancer Center, La Jolla, California, United States

and more 87 locations

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors.

First Posted Date
2019-10-04
Last Posted Date
2024-12-12
Lead Sponsor
Centre Leon Berard
Target Recruit Count
455
Registration Number
NCT04116541
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

Centre Léon Bérard, Lyon, France

🇫🇷

Institut Paoli Calmettes, Marseille, France

and more 5 locations

A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)

Phase 1
Active, not recruiting
Conditions
Solid Tumors, KRAS Mutation; SOS1
Interventions
First Posted Date
2019-10-01
Last Posted Date
2025-03-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
71
Registration Number
NCT04111458
Locations
🇺🇸

Sarah Cannon Research Institute-Nashville-48456, Nashville, Tennessee, United States

🇳🇱

Erasmus Medisch Centrum-ROTTERDAM-50697, Rotterdam, Netherlands

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 5 locations
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