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Intermittent Dosing Of Selumetinib In Childhood NF1 Associated Tumours

NCT03326388 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-04-04

No results posted yet for this study

Summary

Phase I and II study of the MEK inhibitor Selumetinib given twice daily on 5 out of 7 days in children with NF1 and inoperable plexiform neurofibromas or progressive/relapsed optic pathway gliomas.

This study will test the early and late toxicities of selumetinib when it is given in this intermittent schedule (in 5 out of 7 days) and will also test the effectiveness of the drug in reducing the size of plexiform neurofibromas and optic pathway gliomas in children with NF1. It will also test the effectiveness of the drug in improving the participants function in day to day life.

Conditions

  • Neurofibromatosis Type 1
  • Plexiform Neurofibroma
  • Optic Nerve Glioma

Interventions

DRUG

Selumetinib

Selumetinib Intermittent Dosing

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Darren Hargrave, MB Bch · Great Ormond Street Hospital NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2024-02-14
Completion
2024-02-14

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03326388 on ClinicalTrials.gov