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ACTIVE NOT RECRUITING
NCT05101148
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This study in adolescent participants with NF1 who have inoperable PN is designed to evaluate the effect of a low fat meal on steady state selumetinib exposure; to assess the effect on GI tolerability when selumetinib is dosed under fed and fasted conditions; and potentially, to confirm an appropriate dosing recommendation of selumetinib with a low fat meal that maintains efficacy with acceptable safety. These results may support labelling statements with regard to posology and food.

Official title: A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Tolerability and Pharmacokinetics of Selumetinib After Multiple Doses in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2021-07-21

Completion Date

2028-04-28

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

Selumetinib

The dosing regimen for selumetinib (25 mg/m2 bid) will be based on BSA, during T1 and T2 the dose will be 25mg/m2, consistent with the approved prescribing information in the US. If T3 is required, appropriate dose of selumetinib will be defined by Data Review Committee for T3.

Locations (9)

Research Site

Rochester, Minnesota, United States

Research Site

Akron, Ohio, United States

Research Site

Bydgoszcz, Poland

Research Site

Gdansk, Poland

Research Site

Warsaw, Poland

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Barcelona, Spain

Research Site

Madrid, Spain