A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥ 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)
Latest Information Update: 17 May 2025
At a glance
- Drugs Selumetinib (Primary)
- Indications Neurofibromatosis 1; Plexiform neurofibroma
- Focus Adverse reactions; Pharmacokinetics
- Acronyms SPRINKLE
- Sponsors AstraZeneca; AstraZeneca AB
Most Recent Events
- 16 Sep 2024 Planned End Date changed from 8 Feb 2028 to 28 Apr 2028.
- 09 May 2024 Planned End Date changed from 28 Apr 2028 to 8 Feb 2028.
- 09 May 2024 Planned primary completion date changed from 8 Aug 2024 to 9 May 2024.