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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

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

First Posted Date
2021-03-17
Last Posted Date
2023-05-10
Lead Sponsor
Peter MacCallum Cancer Centre, Australia
Target Recruit Count
3
Registration Number
NCT04801966
Locations
🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer

Phase 2
Withdrawn
Conditions
Thyroid Gland Anaplastic Carcinoma
Interventions
First Posted Date
2021-02-04
Last Posted Date
2024-03-25
Lead Sponsor
Saint Petersburg State University, Russia
Registration Number
NCT04739566
Locations
🇷🇺

Saint-Petersburg State University (SPSU) N.I.Pirogov Clinic of High Medical Technologies, Saint Petersburg, Russian Federation

Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

Phase 2
Active, not recruiting
Conditions
Thyroid Gland Anaplastic Carcinoma
Thyroid Gland Squamous Cell Carcinoma
Interventions
Procedure: Conventional Surgery
Radiation: Intensity-Modulated Radiation Therapy
Other: Quality-of-Life Assessment
First Posted Date
2020-12-19
Last Posted Date
2025-02-25
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
30
Registration Number
NCT04675710
Locations
🇺🇸

Stanford School of Medicine, Stanford, California, United States

🇺🇸

University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

and more 3 locations

Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

Recruiting
Conditions
Melanoma
Interventions
First Posted Date
2020-12-14
Last Posted Date
2024-06-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
80
Registration Number
NCT04666272
Locations
🇨🇳

Novartis Investigative Site, Wuhan, China

Enhancing Radioiodine Incorporation Into Radio Iodine Refractory Thyroid Cancers With MAPK Inhibition

First Posted Date
2020-11-06
Last Posted Date
2023-06-22
Lead Sponsor
University Hospital, Essen
Target Recruit Count
70
Registration Number
NCT04619316
Locations
🇩🇪

Manuel M. Weber, Essen, Northrhine-Westphalia, Germany

Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).

Phase 2
Terminated
Conditions
Biliary Cancer
Cholangiocarcinoma
Biliary Tract Neoplasms
Bile Duct Cancer
Interventions
First Posted Date
2020-09-28
Last Posted Date
2023-08-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
2
Registration Number
NCT04566133
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment

Phase 1
Recruiting
Conditions
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma
Interventions
Procedure: Biopsy Procedure
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Echocardiography Test
Procedure: Multigated Acquisition Scan
First Posted Date
2020-09-22
Last Posted Date
2025-05-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
58
Registration Number
NCT04557956
Locations
🇺🇸

UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States

🇺🇸

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States

🇺🇸

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

and more 14 locations

Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection

Conditions
Melanoma
Adjuvant
First Posted Date
2020-09-10
Last Posted Date
2024-11-11
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT04544202

PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

Phase 2
Active, not recruiting
Conditions
Thyroid Cancer, Follicular
Poorly Differentiated Thyroid Gland Carcinoma
Thyroid Cancer
Hurthle Cell Thyroid Neoplasia
Papillary Thyroid Cancer
Follicular Thyroid Cancer
Hurthle Cell Tumor
Interventions
First Posted Date
2020-09-10
Last Posted Date
2025-05-16
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
19
Registration Number
NCT04544111
Locations
🇺🇸

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

🇺🇸

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

and more 4 locations

Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma

Phase 2
Terminated
Conditions
Clinical Stage IV Cutaneous Melanoma AJCC v8
Locally Advanced Melanoma
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Unresectable Melanoma
Pathologic Stage IV Cutaneous Melanoma AJCC v8
Interventions
Drug: Placebo Administration
First Posted Date
2020-08-26
Last Posted Date
2024-08-22
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
5
Registration Number
NCT04527549
Locations
🇺🇸

MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States

🇺🇸

Bethesda North Hospital, Cincinnati, Ohio, United States

🇺🇸

TriHealth Cancer Institute-Westside, Cincinnati, Ohio, United States

and more 196 locations
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