An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1

NCT03259633 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2020-05-01

No results posted yet for this study

Summary

This will be an open-label, single-arm, multicenter intermediate access protocol which provides treatment access to selumetinib for eligible patients with neurofibromatosis type 1 (NF1) who have inoperable, progressive/symptomatic plexiform neurofibromas (PN) without any alternative therapeutic options. All patients will continue to receive drug while they are deriving clinical benefit.

Approximately 100 patients in the US will be treated as part of this protocol

Conditions

  • NF type1 With Inoperable Plexiform Neurofibromas

Interventions

DRUG

Selumetinib

open-label, single-arm, multicenter intermediate access protocol

Sponsors & Collaborators

Principal Investigators

  • Miriam Bornhorst, MD · Investigator

Eligibility

Min Age
2 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

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 NCT03259633 on ClinicalTrials.gov