Trial · NCT02129647
Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
NCT02129647, Phase 2, Completed, NYU Langone Health; results first posted 2021-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas. Trials, record NCT02129647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02129647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
- NCT number
- NCT02129647
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Neurofibromatosis Type 2, Vestibular Schwannomas
- Interventions
- Axitinib
- First posted
- 2014-05-02
- Last updated
- 2021-12-01
- Results first posted
- 2021-12-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Expression Levels of p-S6 Based Immunohistochemistry (Histoscore) | 10 days | The histoscore is given as the sum of the percentage of staining multiplied by an ordinal value corresponding to the intensity level (0 = none, 1 = weak, 2 = moderate, 3 = strong). With 4 intensity levels, the resulting score ranged from 0 (no staining in the tumor) to 300 (diffuse intense staining of the tumor). |
| Primary | Expression Levels of p-ERK Based Immunohistochemistry (Histoscore) | 10 days | The histoscore is given as the sum of the percentage of staining multiplied by an ordinal value corresponding to the intensity level (0 = none, 1 = weak, 2 = moderate, 3 = strong). With 4 intensity levels, the resulting score ranged from 0 (no staining in the tumor) to 300 (diffuse intense staining of the tumor). |
| Primary | Expression Levels of p-AKT Based Immunohistochemistry (Histoscore) | 10 days | The histoscore is given as the sum of the percentage of staining multiplied by an ordinal value corresponding to the intensity level (0 = none, 1 = weak, 2 = moderate, 3 = strong). With 4 intensity levels, the resulting score ranged from 0 (no staining in the tumor) to 300 (diffuse intense staining of the tumor). |
| Primary | Pre-Operative Everolimus Blood Levels | Baseline | |
| Primary | Post-Operative Everolimus Blood Levels | 10 days |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Expression Levels of p-S6 Based Immunohistochemistry (Histoscore) | 10 days | score | MEDIAN | |
| PRIMARY | Expression Levels of p-ERK Based Immunohistochemistry (Histoscore) | 10 days | score | MEDIAN | |
| PRIMARY | Expression Levels of p-AKT Based Immunohistochemistry (Histoscore) | 10 days | score | MEDIAN | |
| PRIMARY | Pre-Operative Everolimus Blood Levels | Baseline | No controls - Given that only a single surgery is generally performed to resect meningiomas and schwannomas without prior biopsy, obtaining matched control of pre and post treatment samples from the same tumor was not feasible. The study team therefore relied on matched archival control tissue for comparisons of other outcome measures; Everolimus blood levels not being one of them. | ng/ml | MEDIAN |
| PRIMARY | Post-Operative Everolimus Blood Levels | 10 days | No controls - Given that only a single surgery is generally performed to resect meningiomas and schwannomas without prior biopsy, obtaining matched control of pre and post treatment samples from the same tumor was not feasible. The study team therefore relied on matched archival control tissue for comparisons of other outcome measures; Everolimus blood levels not being one of them. | ng/ml | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Expression Levels of p-S6 Based Immunohistochemistry (Histoscore) | Axitinib | 90 | Full Range 0 to 220 | score | |
| Expression Levels of p-ERK Based Immunohistochemistry (Histoscore) | Axitinib | 180 | Full Range 40 to 220 | score | |
| Expression Levels of p-AKT Based Immunohistochemistry (Histoscore) | Axitinib | 42 | Full Range 5 to 100 | score | |
| Pre-Operative Everolimus Blood Levels | Axitinib | 17.4 | Full Range 6.9 to 49.6 | ng/ml | |
| Post-Operative Everolimus Blood Levels | Axitinib | 9.4 | Full Range 6.3 to 43.4 | ng/ml |
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 | Axitinib | 13 | |
| Overall Study | COMPLETED | Axitinib | 10 | |
| Overall Study | NOT COMPLETED | Axitinib | 3 |
Source ClinicalTrials.gov
Adverse events4
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 | Mucositis | Gastrointestinal disorders | Axitinib | 3 | 10 | 3 |
| other | nausea | General disorders | Axitinib | 1 | 10 | 1 |
| other | Fatigue | General disorders | Axitinib | 1 | 10 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Axitinib | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Axitinib | 0 | 10 |
| Total, other adverse events | Axitinib | 6 | 10 |
| Total, serious adverse events | Axitinib | 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/NCT02129647
GET https://conductscience.org/api/trials/v1/NCT02129647/registered