Trial · NCT01419639
Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2
NCT01419639, Phase 2, Completed, NYU Langone Health; results first posted 2015-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2. Trials, record NCT01419639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01419639
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2
- NCT number
- NCT01419639
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Neurofibromatosis Type II
- Interventions
- Everolimus (RAD001) , Afinitor®
- First posted
- 2011-08-18
- Last updated
- 2017-07-18
- Results first posted
- 2015-08-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic Response | 1 Year | To estimate the objective response rates to RAD001 in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas. Radiographic response for study purposes = greater than or equal to 15% reduction in tumor volume in any of the target tumors (partial response). Complete disappearance of any of the target tumors = complete response. MRI of the brain and spine will be performed every 3 months. If an objective response (15% reduction in tumor volume compared to baseline) is observed in any target tumor or stable disease, drug will be continued. |
| Primary | Change in Tumor Size From Baseline | 1 Year | |
| Secondary | Audiologic Response | 1 Year | Defined as improvement in speech discrimination score (SDS), defined as an improvement in the score above the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment. Audiologic worsening: decrease in SDS score below the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment. Patients with vestibular schwannomas will receive baseline audiograms within 28 days before enrollments and subsequent audiograms at the time of each MRI. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Response | 1 Year | participants | NUMBER | |
| SECONDARY | Audiologic Response | 1 Year | participants | NUMBER | |
| PRIMARY | Change in Tumor Size From Baseline | 1 Year | % of change in tumor size from baseline | MEDIAN |
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 |
|---|---|---|---|---|---|
| Radiographic Response | RAD001 | 0 | participants | ||
| Audiologic Response | RAD001 | 0 | participants | ||
| Change in Tumor Size From Baseline | RAD001 | 5.72 | Full Range -14 to 25.71 | % of change in tumor size from baseline |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RAD001 | 10 | |
| Overall Study | COMPLETED | RAD001 | 9 | |
| Overall Study | NOT COMPLETED | RAD001 | 1 |
Source ClinicalTrials.gov
Adverse events49
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 | alkaline phosphatase increased | Investigations | RAD001 | 2 | 10 | |
| other | anemia | Blood and lymphatic system disorders | RAD001 | 5 | 10 | |
| other | anxiety | Psychiatric disorders | RAD001 | 1 | 10 | |
| other | arthralgia | Musculoskeletal and connective tissue disorders | RAD001 | 1 | 10 | |
| other | AST increased | Investigations | RAD001 | 3 | 10 | |
| other | azoospermia | Reproductive system and breast disorders | RAD001 | 1 | 10 | |
| other | bruising | Injury, poisoning and procedural complications | RAD001 | 1 | 10 | |
| other | chills | General disorders | RAD001 | 1 | 10 | |
| other | cholesterol high | Investigations | RAD001 | 7 | 10 | |
| other | constipation | Gastrointestinal disorders | RAD001 | 1 | 10 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RAD001 | ||
| Total, other adverse events | RAD001 | 10 | 10 |
| Total, serious adverse events | RAD001 | 0 | 10 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01419639
GET https://conductscience.org/api/trials/v1/NCT01419639/events?page=2