Trial · NCT03231306
Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas
NCT03231306, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2025-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas. Trials, record NCT03231306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03231306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas
- NCT number
- NCT03231306
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Neurofibromatosis Type 1, Plexiform Neurofibroma
- Interventions
- Binimetinib
- First posted
- 2017-07-27
- Last updated
- 2025-05-02
- Results first posted
- 2025-05-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Target Tumor Volume at 12 Months | Approximately 12 months | To determine the objective response defined as 20% or greater tumor volume reduction. Patients will undergo volumetric assays of their target PN using MRI. |
| Secondary | Incidence of Treatment-Emergent Adverse Events | Up to 24 months | To evaluate the toxicity of protracted binimetinib administration in this patient population. Subjects will be monitored continuously for adverse events and serious adverse events throughout the study. |
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 | Change From Baseline Target Tumor Volume at 12 Months | Approximately 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Treatment-Emergent Adverse Events | Up to 24 months | 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 |
|---|---|---|---|---|---|
| Change From Baseline Target Tumor Volume at 12 Months | Open Label Study of Binimetinib (MEK162) | Met Objective Response | 27 | Participants | |
| Change From Baseline Target Tumor Volume at 12 Months | Open Label Study of Binimetinib (MEK162) | Did Not Meet Objective Response | 17 | Participants | |
| Incidence of Treatment-Emergent Adverse Events | Open Label Study of Binimetinib (MEK162) | 45 | 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 | Open Label Study of Binimetinib (MEK162) | 45 | |
| Overall Study | COMPLETED | Open Label Study of Binimetinib (MEK162) | 19 | |
| Overall Study | NOT COMPLETED | Open Label Study of Binimetinib (MEK162) | 26 |
Source ClinicalTrials.gov
Adverse events214
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 | Anemia | Blood and lymphatic system disorders | Open Label Study of Binimetinib (MEK162) | 16 | 45 | 36 |
| other | Cardiac disorders - Other, Non-Specific St And T-Wave Abnormalities | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 1 | 45 | 1 |
| other | Cardiac disorders - Other, Nonspecific T Wave Abnormality | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 1 | 45 | 1 |
| other | Cardiac disorders - Other, Specify, Electrocardiogram T Wave Abnormal | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 2 | 45 | 2 |
| other | Cardiac disorders - Other, Systolic Murmur | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 1 | 45 | 1 |
| other | Cardiac disorders - Other, Tachycardia | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 1 | 45 | 1 |
| other | Conduction disorder | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 1 | 45 | 1 |
| other | Pulmonary Valve Disease | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 1 | 45 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 1 | 45 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Open Label Study of Binimetinib (MEK162) | 4 | 45 | 8 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label Study of Binimetinib (MEK162) | 0 | 45 |
| Total, other adverse events | Open Label Study of Binimetinib (MEK162) | 45 | 45 |
| Total, serious adverse events | Open Label Study of Binimetinib (MEK162) | 11 | 45 |
Source ClinicalTrials.gov
Papers24
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/NCT03231306
GET https://conductscience.org/api/trials/v1/NCT03231306/events?page=2