Trial · NCT03095248
Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors
NCT03095248, Phase 2, Terminated, Children's Hospital Medical Center, Cincinnati; results first posted 2025-04-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors. Trials, record NCT03095248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03095248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors
- NCT number
- NCT03095248
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Neurofibromatosis 2, Vestibular Schwannoma, Meningioma, Ependymoma, Glioma
- Interventions
- Selumetinib
- First posted
- 2017-03-29
- Last updated
- 2025-04-22
- Results first posted
- 2025-04-22
- Limitations and caveats
- Early termination due to not meeting study endpoints as defined per protocol.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stratum 1- Number of Patients With Hearing Response at 24 Weeks as Measured by Word Recognition | 24 weeks | 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 percentage identified correctly is the score. This study will use full 50-item monosyllable lists and standardized recordings. This Outcome Measure was pre-specified to be assessed only within the Stratum 1 Arm/Group. |
| Primary | Radiographic Tumor Response | Through study completion up to 2 years | To determine the radiographic response rate for Stratum 1 and Stratum 2. Specifics for each stratum are defined in the Arms/ Groups. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stratum 1- Number of Patients With Hearing Response at 24 Weeks as Measured by Word Recognition | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Radiographic Tumor Response | Through study completion up to 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stratum 1- Number of Patients With Hearing Response at 24 Weeks as Measured by Word Recognition | Stratum 1 - NF2 Related Vestibular Schwannomas | 0 | Participants | ||
| Radiographic Tumor Response | Stratum 1: NF2 Tumor (Vestibular Schwanomas) | 1 | Participants | ||
| Radiographic Tumor Response | Stratum 2- NF2 Tumors (Non-vestibular Schwanoma (VS)) | 9 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum 1 - NF2 Related Vestibular Schwannomas | 1 | |
| Overall Study | STARTED | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 9 | |
| Overall Study | COMPLETED | Stratum 1 - NF2 Related Vestibular Schwannomas | 1 | |
| Overall Study | COMPLETED | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 9 | |
| Overall Study | NOT COMPLETED | Stratum 1 - NF2 Related Vestibular Schwannomas | 0 | |
| Overall Study | NOT COMPLETED | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 0 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | CPK increased | Investigations | Stratum 1 - NF2 Related Vestibular Schwannomas | 1 | 1 | 1 |
| other | CPK increased | Investigations | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 1 | 9 | 1 |
| other | Cataract | Eye disorders | Stratum 1 - NF2 Related Vestibular Schwannomas | 0 | 1 | 0 |
| other | Cataract | Eye disorders | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 1 | 9 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Stratum 1 - NF2 Related Vestibular Schwannomas | 0 | 1 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 2 | 9 | 2 |
| other | Nausea | Gastrointestinal disorders | Stratum 1 - NF2 Related Vestibular Schwannomas | 0 | 1 | 0 |
| other | Nausea | Gastrointestinal disorders | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 2 | 9 | 2 |
| other | Gastrointestinal disorders-other: mouth sores | Gastrointestinal disorders | Stratum 1 - NF2 Related Vestibular Schwannomas | 0 | 1 | 0 |
| other | Gastrointestinal disorders-other: mouth sores | Gastrointestinal disorders | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 1 | 9 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1 - NF2 Related Vestibular Schwannomas | 0 | 1 |
| Total, all-cause mortality | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 0 | 9 |
| Total, other adverse events | Stratum 1 - NF2 Related Vestibular Schwannomas | 1 | 1 |
| Total, other adverse events | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 9 | 9 |
| Total, serious adverse events | Stratum 1 - NF2 Related Vestibular Schwannomas | 1 | 1 |
| Total, serious adverse events | Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma) | 2 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Stratum 1: NF2 Tumor (Vestibular Schwanomas) vs Stratum 2- NF2 Tumors (Non-vestibular Schwanoma (VS)): Radiographic Tumor Response | Trial comparisons |
| Stratum 1 - NF2 Related Vestibular Schwannomas vs Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma): deaths from any cause | Trial comparisons |
| Stratum 1 - NF2 Related Vestibular Schwannomas vs Stratum 2: Other NF2 Related Tumors (Meningiomas and Ependymoma): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03095248
GET https://conductscience.org/api/trials/v1/NCT03095248/events?page=2