Trial · NCT02101736
Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults
NCT02101736, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2023-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults. Trials, record NCT02101736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02101736
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults
- NCT number
- NCT02101736
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- NF1, Neurofibromatosis, Plexiform Neurofibromas
- Interventions
- Cabozantinib
- First posted
- 2014-04-02
- Last updated
- 2023-05-24
- Results first posted
- 2023-05-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Tumor Size Based on Radiographic Assessment | baseline to 12 Months | We will estimate the objective response rate (ORR) as defined by 20% volumetric MRI response of the target lesion to cabozantinib at 12 months in adolescents and adults with Neurofibromatosis type 1 (NF1) plexiform neurofibromas by volumetric MRI imaging. |
| Secondary | Number of Participants With Adverse Events | baseline to 24 months | This is the number of participants with one or more adverse events. |
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 | The Change in Tumor Size Based on Radiographic Assessment | baseline to 12 Months | There were a total of 19 evaluable subjects from Cohort A and 21 for Cohort B. | mm^3 | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | baseline to 24 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Tumor Size Based on Radiographic Assessment | Cohort A | -15.7 | Full Range -38 to 2.8 | mm^3 | |
| The Change in Tumor Size Based on Radiographic Assessment | Cohort B | -4.1 | Full Range -25.8 to 12.5 | mm^3 | |
| Number of Participants With Adverse Events | Cohort A | 20 | Participants | ||
| Number of Participants With Adverse Events | Cohort B | 21 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 23 | |
| Overall Study | STARTED | Cohort B | 22 | |
| Overall Study | COMPLETED | Cohort A | 19 | |
| Overall Study | COMPLETED | Cohort B | 21 | |
| Overall Study | NOT COMPLETED | Cohort A | 4 | |
| Overall Study | NOT COMPLETED | Cohort B | 1 |
Source ClinicalTrials.gov
Adverse events414
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 | Cohort A | 0 | 23 | 0 |
| other | ANEMIA | Blood and lymphatic system disorders | Cohort B | 1 | 22 | 1 |
| other | PALPITATIONS | Cardiac disorders | Cohort A | 1 | 23 | 2 |
| other | PALPITATIONS | Cardiac disorders | Cohort B | 0 | 22 | 0 |
| other | SINUS BRADYCARDIA | Cardiac disorders | Cohort A | 2 | 23 | 6 |
| other | SINUS BRADYCARDIA | Cardiac disorders | Cohort B | 1 | 22 | 2 |
| other | VERTIGO | Ear and labyrinth disorders | Cohort A | 2 | 23 | 4 |
| other | VERTIGO | Ear and labyrinth disorders | Cohort B | 0 | 22 | 0 |
| other | HYPERTHYROIDISM | Endocrine disorders | Cohort A | 1 | 23 | 2 |
| other | HYPERTHYROIDISM | Endocrine disorders | Cohort B | 1 | 22 | 1 |
1 to 10 of 414Source ClinicalTrials.gov
See all 414 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 0 | 23 |
| Total, all-cause mortality | Cohort B | 0 | 22 |
| Total, other adverse events | Cohort A | 21 | 23 |
| Total, other adverse events | Cohort B | 22 | 22 |
| Total, serious adverse events | Cohort A | 2 | 23 |
| Total, serious adverse events | Cohort B | 5 | 22 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A vs Cohort B: Number of Participants With Adverse Events | Trial comparisons |
| Cohort A vs Cohort B: deaths from any cause | Trial comparisons |
| Cohort A vs Cohort B: serious adverse events | Trial comparisons |
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/NCT02101736
GET https://conductscience.org/api/trials/v1/NCT02101736/events?page=2