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

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

Phase 3

Recruiting

Conditions: Advanced or Metastatic NRAS-mutant Melanoma

Interventions: Drug: Naporafenib
Drug: Dacarbazine
Drug: Trametinib
Drug: Temozolomide

First Posted Date: 2024-04-03

Last Posted Date: 2025-01-17

Lead Sponsor: Erasca, Inc.

Target Recruit Count: 470

Registration Number: NCT06346067

Locations: 🇺🇸
Mayo Clinic - Arizona, Phoenix, Arizona, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
The Melanoma and Skin Care Institute, Englewood, Colorado, United States

and more 56 locations

Precision Cancer Therapy in Rare Cancers

Phase 2

Recruiting

Conditions: Rare Malignant Neoplasm

Interventions: Drug: Imatinib
Drug: Trametinib
Drug: Dabrafenib

First Posted Date: 2023-11-07

Last Posted Date: 2025-03-26

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 96

Registration Number: NCT06119789

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway

Pilot Study on Trametinib for Surgical Unruptured AVMs

Phase 2

Recruiting

Conditions: Arteriovenous Malformations

Interventions: Drug: Trametinib tablet

First Posted Date: 2023-10-25

Last Posted Date: 2024-05-30

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 10

Registration Number: NCT06098872

Locations: 🇨🇦
University Health Network, Toronto, Ontario, Canada

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations

Phase 1

Recruiting

Conditions: Advanced or Metastatic Solid Tumors

Interventions: Drug: Naporafenib
Drug: Trametinib

First Posted Date: 2023-06-18

Last Posted Date: 2025-01-07

Lead Sponsor: Erasca, Inc.

Target Recruit Count: 115

Registration Number: NCT05907304

Locations: 🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Inova Schar Cancer Institute, Fairfax, Virginia, United States
🇺🇸
University of Alabama, Birmingham, Alabama, United States

and more 27 locations

Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations

Phase 2

Recruiting

Conditions: Cancer

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2023-05-25

Last Posted Date: 2023-11-30

Lead Sponsor: Se Jun Park

Target Recruit Count: 30

Registration Number: NCT05876806

Locations: 🇰🇷
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea, Republic of

Combination of GNS561 and Trametinib in Patients with Advanced KRAS Mutated Cholangiocarcinoma

Phase 1

Recruiting

Conditions: Cholangiocarcinoma

Interventions: Drug: GNS561 + Trametinib

First Posted Date: 2023-05-24

Last Posted Date: 2024-11-21

Lead Sponsor: Genfit

Target Recruit Count: 74

Registration Number: NCT05874414

Locations: 🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University Of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

and more 5 locations

A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia

Phase 1

Recruiting

Conditions: CBL Syndrome
JMML
Neurofibromatosis 1
JCML
Leukemia, Juvenile Myelomonocytic

Interventions: Drug: Trametinib
Drug: Azacitidine
Drug: Fludarabine
Drug: Cytarabine

First Posted Date: 2023-05-09

Last Posted Date: 2024-11-11

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 58

Registration Number: NCT05849662

Locations: 🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 1 locations

Testing the Safety and Effectiveness of Combining Two Drugs, PLX2853 and Trametinib in the Treatment of Advanced Uveal Melanoma

Phase 1

Withdrawn

Conditions: Advanced Uveal Melanoma
Metastatic Uveal Melanoma
Unresectable Uveal Melanoma

Interventions: Drug: BRD4 Inhibitor PLX2853
Drug: Trametinib
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Biospecimen collection

First Posted Date: 2023-01-10

Last Posted Date: 2023-08-18

Lead Sponsor: Alliance for Clinical Trials in Oncology

Registration Number: NCT05677373

A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors

Phase 1

Active, not recruiting

Conditions: Solid Tumors
Melanoma
NSCLC
CRC
ATC

Interventions: Drug: CFT1946
Drug: Trametinib
Drug: Cetuximab

First Posted Date: 2022-12-30

Last Posted Date: 2025-05-13

Lead Sponsor: C4 Therapeutics, Inc.

Target Recruit Count: 89

Registration Number: NCT05668585

Locations: 🇫🇷
Chu de Lille, Lille, France
🇫🇷
Institut Bergonie, Bordeaux Cedex, France
🇺🇸
University of Arizona - Cancer Center, Tucson, Arizona, United States

and more 23 locations

HEM ISMART-D: Trametinib + Dexamethasone + Chemotherapy in Children with Relapsed or Refractory Hematological Malignancies

Phase 1

Recruiting

Conditions: Acute Lymphoblastic Leukemia, in Relapse
Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent
Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory
Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent

Interventions: Drug: Trametinib
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Intrathecal chemotherapy

First Posted Date: 2022-12-21

Last Posted Date: 2024-11-11

Lead Sponsor: Princess Maxima Center for Pediatric Oncology

Target Recruit Count: 26

Registration Number: NCT05658640

Locations: 🇦🇹
St. Anna Kinderspital, Vienna, Austria
🇧🇪
Universitair Ziekenhuis Gent, Gent, Belgium
🇩🇰
Rigshospitalet Copenhagen, Copenhagen, Denmark

and more 33 locations

Drug Development Updates

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