Selumetinib

Generic Name
Selumetinib
Brand Names
Koselugo
Drug Type
Small Molecule
Chemical Formula
C17H15BrClFN4O3
CAS Number
606143-52-6
Unique Ingredient Identifier
6UH91I579U
Background

Activation of the Raf-MEK-ERK signaling pathway is known to be implemented in several types of malignancies, thus, mitogen-activated protein kinase kinase (MEK) inhibitors such as selumetinib are important tools that can target the problematic overactivity of this pathway.
...

Indication

Although selumetinib has been investigated for the treatment of several types of cancer, it is currently only indicated for the treatment of neurofibromatosis type 1 (NF1) in patients ≥2 years who have symptomatic, inoperable plexiform neurofibromas (PN).

Associated Conditions
Neurofibromatosis, type 1 (von Recklinghausen's disease)
Associated Therapies
-

Early Phase Study Evaluating MEK and MDM2 Inhibition in Patients With NF1 and MPNST

First Posted Date
2024-12-16
Last Posted Date
2024-12-16
Lead Sponsor
AeRang Kim
Target Recruit Count
45
Registration Number
NCT06735820
Locations
🇺🇸

Children's National Hospital, Washington, District of Columbia, United States

The Clinical Study of the Treatment of Patients With Type I Neurofibromatosis With Smetinib Hydrosulfate Capsule

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2024-10-01
Last Posted Date
2024-10-01
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
19
Registration Number
NCT06621082

Clinical Study on the Treatment of Type I Neurofibromatosis With Smeitinib Hydrosulfate Capsule

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2024-10-01
Last Posted Date
2024-10-01
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
33
Registration Number
NCT06620354

Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2024-01-03
Last Posted Date
2024-10-11
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
200
Registration Number
NCT06188741

Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2022-02-23
Last Posted Date
2024-06-14
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
41
Registration Number
NCT05253131
Locations
🇺🇸

National Cancer Institute (NCI), Bethesda, Maryland, United States

🇺🇸

Washington University - St. Louis, Saint Louis, Missouri, United States

🇺🇸

New York University Medical Center, New York, New York, United States

and more 11 locations

Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-11-01
Last Posted Date
2024-12-10
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT05101148
Locations
🇪🇸

Research Site, Madrid, Spain

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-06-14
Last Posted Date
2024-12-09
Lead Sponsor
AstraZeneca
Target Recruit Count
146
Registration Number
NCT04924608
Locations
🇬🇧

Research Site, Manchester, United Kingdom

A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-10-19
Last Posted Date
2024-11-19
Lead Sponsor
AstraZeneca
Target Recruit Count
32
Registration Number
NCT04590235
Locations
🇨🇳

Research Site, Shanghai, China

Selumetinib Paediatric NF1 Japan Study

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-07-31
Last Posted Date
2023-04-26
Lead Sponsor
AstraZeneca
Target Recruit Count
12
Registration Number
NCT04495127
Locations
🇯🇵

Research Site, Setagaya-ku, Japan

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