Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
Conditions
Interventions
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