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NCT03095248 · ClinicalTrials.gov registry record · Phase 2
Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03095248: Clinical Trial Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03095248 is a Phase 2 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095248, a Phase 2 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
The primary endpoint for the Stratum 1 is hearing response at 24 weeks, defined as an improvement in word recognition score above the 95% critical difference, taking as reference the baseline word recognition score. Audiology will include measurement of pure tone thresholds and determination of word recognition scores. Word recognition scores measure the ability to recognize (as opposed to detect) auditory information. Patients are presented a list of 50 words at a fully audible level and the pe
Interventions
- DRUG Selumetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2024-05-21 |
| Phase | Phase 2 |
Why NCT03095248 stopped before completion
NCT03095248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Selumetinib is the first listed.
NCT03095248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03095248 about?
NCT03095248 is a clinical study titled "Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors". 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 ha...
What is the current status of trial NCT03095248?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2017-05-08. Estimated completion is 2024-05-21.
What interventions are being tested in trial NCT03095248?
The interventions under investigation include: Selumetinib (DRUG).
Who is sponsoring clinical trial NCT03095248?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03095248's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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