NCT05309668 · MORE INFO

Limitations, agreements, and source contact

Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN · Source last updated 2026-08-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement

pi Sponsor Employee: false
restrictive Agreement: false

limitations And Caveats

description: The outcome measure "Primary Outcome: Selumetininb AUC0-12₂ Derived After Single Dose Administration" is one of two co-primary endpoints. The second co-primary endpoint - "Adverse Events Graded by CTCAE Version 5.0" - is still ongoing. As a result, the study has not yet reached the Primary Completion Date at the time these results were submitted. Full results, including data for the second co-primary endpoint, will be submitted upon completion of the study.

point Of Contact

email: information.center@astrazeneca.com
organization: AstraZeneca
phone: 1-877-240-9479
title: Global Clinical Lead

Complete source fields

certain Agreement

pi Sponsor Employee: false
restrictive Agreement: false

limitations And Caveats

description: The outcome measure "Primary Outcome: Selumetininb AUC0-12₂ Derived After Single Dose Administration" is one of two co-primary endpoints. The second co-primary endpoint - "Adverse Events Graded by CTCAE Version 5.0" - is still ongoing. As a result, the study has not yet reached the Primary Completion Date at the time these results were submitted. Full results, including data for the second co-primary endpoint, will be submitted upon completion of the study.

point Of Contact

email: information.center@astrazeneca.com
organization: AstraZeneca
phone: 1-877-240-9479
title: Global Clinical Lead

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice