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 c...

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:
...

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
Associated Therapies
-

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-04-28
Last Posted Date
2021-07-14
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
139
Registration Number
NCT02124772
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma

First Posted Date
2014-04-10
Last Posted Date
2021-03-26
Lead Sponsor
Kartos Therapeutics, Inc.
Target Recruit Count
31
Registration Number
NCT02110355
Locations
🇦🇺

Research Site, Melbourne, Victoria, Australia

Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-03-11
Last Posted Date
2022-02-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
77
Registration Number
NCT02083354
Locations
🇹🇭

Novartis Investigative Site, Songkla, Thailand

Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors

First Posted Date
2014-03-06
Last Posted Date
2024-03-12
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
97
Registration Number
NCT02079740
Locations
🇺🇸

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

🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction

First Posted Date
2014-02-25
Last Posted Date
2024-12-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
46
Registration Number
NCT02070549
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

🇺🇸

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

and more 8 locations

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-02-17
Last Posted Date
2018-06-01
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
28
Registration Number
NCT02065063
Locations
🇺🇸

GSK Investigational Site, Houston, Texas, United States

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

First Posted Date
2014-01-20
Last Posted Date
2019-05-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
127
Registration Number
NCT02039947
Locations
🇪🇸

Novartis Investigative Site, Zaragoza, Spain

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-01-13
Last Posted Date
2023-08-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
206
Registration Number
NCT02034110
Locations
🇸🇪

Novartis Investigative Site, Stockholm, Sweden

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