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Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors

NCT03095248 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-22

Study results available
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Summary

In this research study the researchers want to learn more about the effects (both good and bad) the study drug selumetinib has on participants with neurofibromatosis type II (NF2) related tumor.

The researchers are asking patients with NF2 related tumors to be in the study, because their hearing has decreased and/or their NF2 related tumor has started to grow.

The goals of this study are:

* Determine if selumetinib will stop NF2 related tumors from growing
* Measure the changes in hearing after receiving selumetinib for 6 months.
* Determine if selumetinib improves how participants feel (physically and emotionally) and how participants can perform daily activities.
* Examine tumor tissue, if available, in a laboratory to see if NF2 related tumors have targets of selumetinib.

Conditions

Interventions

DRUG

Selumetinib

Continuous twice daily dosing; oral agent

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Trent Hummel, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2024-05-21
Completion
2024-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
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 NCT03095248 on ClinicalTrials.gov