Trial · NCT01767792
Phase 2 Study of Bevacizumab in Children and Young Adults With NF 2 and Progressive Vestibular Schwannomas
NCT01767792, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2020-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Bevacizumab in Children and Young Adults With NF 2 and Progressive Vestibular Schwannomas. Trials, record NCT01767792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01767792
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Bevacizumab in Children and Young Adults With NF 2 and Progressive Vestibular Schwannomas
- NCT number
- NCT01767792
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Neurofibromatosis Type 2, Progressive Vestibular Schwannomas
- Interventions
- Bevacizumab
- First posted
- 2013-01-14
- Last updated
- 2021-02-12
- Results first posted
- 2020-05-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Hearing | 6 months | Number of participants with a statistically significant increase in word recognition score on audiology compared to baseline. |
| Secondary | Number of Participants With Adverse Events | 6 months | Number of participants with adverse events occurring in at least 10% of participants during induction therapy. |
| Secondary | Tolerability of Bevacizumab During Induction (High Dose) Therapy | 6 months | Number of participants who did not stop treatment due to side effects or by participant/provider choice during induction period. |
| Secondary | Durability of Hearing Response During Maintenance (Low Dose) Therapy | 2 years | Number of participants with hearing improvement during induction therapy who maintained hearing improvement relative to baseline during maintenance therapy as measured by word recognition score. |
| Secondary | Changes in Pure Tone Average (PTA) on Audiology Compared With Baseline, Measured in Decibels (dBHL). | Weeks 25, 49, 73, 98 | Increase in pure tone average represents worsening of hearing and decrease in pure tone average represents improvement of hearing. Range for for pure tone average (PTA) is 0-110 dBHL (decibels). |
| Secondary | Changes in Distress Related to Tinnitus During Induction (High Dose) Treatment. | 6 months (induction phase) | Self-reported distress measured using the tinnitus reaction questionnaire (TRQ). TRQ has 26 questions measured on a 5-point Likert scale from 0 (not at all) to 4 (almost all of the time). The total score is the sum of the responses with higher scores indicating more reported distress. |
| Secondary | Durability of Radiographic Response | 2 years | Count of participants who achieved a 20% or more reduction in tumor volume over baseline during induction (high dose) therapy and maintained this decrease during maintenance (low dose) therapy (decline in tumor volume from baseline of 20% or more). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement in Hearing | 6 months | All participants treated with bevacizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | 6 months | All participants treated with bevacizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tolerability of Bevacizumab During Induction (High Dose) Therapy | 6 months | All participants treated with bevacizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Durability of Hearing Response During Maintenance (Low Dose) Therapy | 2 years | Analysis population is restricted to participants who achieved hearing improvement during induction (high dose) therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Pure Tone Average (PTA) on Audiology Compared With Baseline, Measured in Decibels (dBHL). | Weeks 25, 49, 73, 98 | All participants treated during maintenance (low dose) therapy. | decibels (dBHL) | LEAST_SQUARES_MEAN |
| SECONDARY | Changes in Distress Related to Tinnitus During Induction (High Dose) Treatment. | 6 months (induction phase) | Number of participants with data at baseline and month 6. | units on a scale | MEAN |
| SECONDARY | Durability of Radiographic Response | 2 years | Analysis population is restricted to participants who achieved hearing improvement during induction (high dose) therapy. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improvement in Hearing | Bevacizumab | 9 | Participants | ||
| Number of Participants With Adverse Events | Bevacizumab | 22 | Participants | ||
| Tolerability of Bevacizumab During Induction (High Dose) Therapy | Bevacizumab | 21 | Participants | ||
| Durability of Hearing Response During Maintenance (Low Dose) Therapy | Bevacizumab | 4 | Participants | ||
| Changes in Pure Tone Average (PTA) on Audiology Compared With Baseline, Measured in Decibels (dBHL). | Bevacizumab | Change from week 25 to week 49 | -1.19 | Standard Error 1.91 | decibels (dBHL) |
| Changes in Pure Tone Average (PTA) on Audiology Compared With Baseline, Measured in Decibels (dBHL). | Bevacizumab | Change from week 25 to week 73 | 1.05 | Standard Error 1.91 | decibels (dBHL) |
| Changes in Pure Tone Average (PTA) on Audiology Compared With Baseline, Measured in Decibels (dBHL). | Bevacizumab | Change from week 25 to week 98 | -0.95 | Standard Error 2.09 | decibels (dBHL) |
| Changes in Distress Related to Tinnitus During Induction (High Dose) Treatment. | Bevacizumab | 14.3 | Standard Deviation 18.2 | units on a scale | |
| Durability of Radiographic Response | Bevacizumab | 5 | Participants |
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 | Bevacizumab | 22 | |
| Overall Study | COMPLETED | Bevacizumab | 20 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 2 |
Source ClinicalTrials.gov
Adverse events15
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 | Hypertension | Vascular disorders | Bevacizumab | 11 | 22 | 28 |
| other | Fatigue | Nervous system disorders | Bevacizumab | 8 | 22 | 17 |
| other | Headache | Nervous system disorders | Bevacizumab | 7 | 22 | 13 |
| other | Irregular menstruation | Reproductive system and breast disorders | Bevacizumab | 6 | 22 | 9 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Bevacizumab | 5 | 22 | 8 |
| other | Diarrhea | Gastrointestinal disorders | Bevacizumab | 4 | 22 | 6 |
| other | Nausea | Gastrointestinal disorders | Bevacizumab | 4 | 22 | 5 |
| other | Proteinuria | Renal and urinary disorders | Bevacizumab | 4 | 22 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab | 3 | 22 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Bevacizumab | 3 | 22 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | 0 | 22 |
| Total, other adverse events | Bevacizumab | 22 | 22 |
| Total, serious adverse events | Bevacizumab | 1 | 22 |
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/NCT01767792
GET https://conductscience.org/api/trials/v1/NCT01767792/registered