Trial · NCT02282917
Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
NCT02282917, Early phase 1, Terminated, Massachusetts Eye and Ear Infirmary; results first posted 2022-05-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma. Trials, record NCT02282917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02282917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
- NCT number
- NCT02282917
- Status
- Terminated
- Phases
- Early phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Conditions
- Vestibular Schwannoma, Meningioma, Acoustic Neuroma, Neurofibromatosis Type 2
- Interventions
- AR-42
- First posted
- 2014-11-05
- Last updated
- 2026-10-28
- Results first posted
- 2022-05-11
- Limitations and caveats
The supplier of AR-42 was unable to continue to supply drugs after 2017. We elected to present the data on five of the originally planned 20 patients. Accrual was also limited by patient willingness to accept potential additional peri-operative risk without a reasonable likelihood of benefit from only 3 weeks of therapy with AR-42. Other limitations include possible selection bias, lack of control subjects, and the inability to perform meaningful statistical analysis.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Phospho-AKT (p-AKT) to AKT After 3 Weeks of Oral AR-42 | 3 weeks | The phospho-AKT/AKT ratio was used to estimate the activity of AKT, a kinase, at the core of resected tumors. Quantitation of the normalized p-AKT/AKT ratio is depicted as a percentage relative to the untreated VS2 set as 100%. For example, a value under 100% indicates a lower level of AKT activity relative to untreated VS2 tumors. Phosphorylated AKT, or phospho-AKT, is the activated form of AKT. These measurements were derived from the core of the resected tumors. |
| Primary | Peripheral Phospho-AKT (p-AKT) to AKT Ratio After 3 Weeks of Oral AR-42 | 3 weeks | The phospho-AKT/AKT ratio was used to estimate the activity of AKT, a kinase, at the core of resected tumors. Quantitation of the normalized p-AKT/AKT ratio is depicted as a percentage relative to the untreated VS2 set as 100%. For example, a value under 100% indicates a lower level of AKT activity relative to untreated patients. Phosphorylated AKT, or phospho-AKT, is the activated form of AKT. These measurements were derived from the periphery of the resected tumors. |
| Secondary | AR-42 Plasma Concentration | 1 week | Steady-state plasma concentrations of AR-42 at the time of tumor resection are provided. |
| Secondary | AR-42 Tumor Concentration (Capsule) | 1 week | Concentrations of AR-42 at the tumor capsule are provided. |
| Secondary | AR-42 Tumor Concentration (Center) | 1 week | Intra-tumor concentrations of AR-42 at the tumor center are reported. |
| Secondary | AR-42 Tumor Concentration (Capsule/Plasma) | 1 week | Capsule/plasma intra-tumor AR-42 concentrations are provided as a ratio. |
| Secondary | AR-42 Tumor Concentration (Center/Plasma) | 1 week | Center/plasma intra-tumoral AR-42 concentrations are provided as a ratio. |
| Other | Number of Doses of AR-42 Received | 3 weeks | We report the average total number of doses of AR-42 taken per participant during this study. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Phospho-AKT (p-AKT) to AKT After 3 Weeks of Oral AR-42 | 3 weeks | percent (%) | MEAN | |
| PRIMARY | Peripheral Phospho-AKT (p-AKT) to AKT Ratio After 3 Weeks of Oral AR-42 | 3 weeks | percent (%) | MEAN | |
| SECONDARY | AR-42 Plasma Concentration | 1 week | nanomolar (nM) | MEAN | |
| SECONDARY | AR-42 Tumor Concentration (Capsule) | 1 week | nanomolar (nM) | MEAN | |
| SECONDARY | AR-42 Tumor Concentration (Center) | 1 week | nanomolar (nM) | MEAN | |
| SECONDARY | AR-42 Tumor Concentration (Capsule/Plasma) | 1 week | ratio | MEAN | |
| SECONDARY | AR-42 Tumor Concentration (Center/Plasma) | 1 week | ratio | MEAN | |
| OTHER_PRE_SPECIFIED | Number of Doses of AR-42 Received | 3 weeks | total doses | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio of Phospho-AKT (p-AKT) to AKT After 3 Weeks of Oral AR-42 | AR-42 Administration | 53.6 | Full Range 19 to 105 | percent (%) | |
| Peripheral Phospho-AKT (p-AKT) to AKT Ratio After 3 Weeks of Oral AR-42 | AR-42 Administration | 61.2 | Full Range 9 to 102 | percent (%) | |
| AR-42 Plasma Concentration | AR-42 Administration | 107.58 | Full Range 3.4 to 303.7 | nanomolar (nM) | |
| AR-42 Tumor Concentration (Capsule) | AR-42 Administration | 325.1 | Full Range 16.2 to 5296.6 | nanomolar (nM) | |
| AR-42 Tumor Concentration (Center) | AR-42 Administration | 645.18 | Full Range 7.1 to 1766.2 | nanomolar (nM) | |
| AR-42 Tumor Concentration (Capsule/Plasma) | AR-42 Administration | 13.078 | Full Range 1.72 to 53.4 | ratio | |
| AR-42 Tumor Concentration (Center/Plasma) | AR-42 Administration | 5.748 | Full Range 1.59 to 17.8 | ratio | |
| Number of Doses of AR-42 Received | AR-42 Administration | 9 | Full Range 8 to 11 | total doses |
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 | AR-42 Administration | 7 | |
| Overall Study | COMPLETED | AR-42 Administration | 5 | |
| Overall Study | NOT COMPLETED | AR-42 Administration | 2 |
Source ClinicalTrials.gov
Adverse events20
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 | Thrombocytopenia | Blood and lymphatic system disorders | AR-42 Administration | 3 | 5 | |
| other | Fatigue | General disorders | AR-42 Administration | 3 | 5 | |
| other | Nausea | General disorders | AR-42 Administration | 2 | 5 | |
| other | Diarrhea | Gastrointestinal disorders | AR-42 Administration | 1 | 5 | |
| other | Anemia | Blood and lymphatic system disorders | AR-42 Administration | 2 | 5 | |
| other | Leukopenia | Blood and lymphatic system disorders | AR-42 Administration | 3 | 5 | |
| other | Neutropenia | Blood and lymphatic system disorders | AR-42 Administration | 1 | 5 | |
| other | Confusion | Psychiatric disorders | AR-42 Administration | 4 | 5 | |
| other | Lymphopenia | Blood and lymphatic system disorders | AR-42 Administration | 1 | 5 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | AR-42 Administration | 1 | 5 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AR-42 Administration | 0 | 5 |
| Total, other adverse events | AR-42 Administration | 4 | 5 |
| Total, serious adverse events | AR-42 Administration | 0 | 5 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02282917
GET https://conductscience.org/api/trials/v1/NCT02282917/registered