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

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.

Timeline

Start

2021-07-21

Primary completion

2022-04-06

Completion

2028-04-28

Publications

• Viskochil D, Wysocki M, Learoyd M, Sun P, So K, Evans A, Lai F, Hernandez HS. Effect of food on selumetinib pharmacokinetics and gastrointestinal tolerability in adolescents with neurofibromatosis type 1-related plexiform neurofibromas. Neurooncol Adv. 2024 Mar 16;6(1):vdae036. doi: 10.1093/noajnl/vdae036. eCollection 2024 Jan-Dec.

Drugs

Indications