Trial · NCT01338857
Sorafenib in Children and Young Adults With Recurrent or Progressive Low-Grade Astrocytomas
NCT01338857, Phase 2, Terminated, NYU Langone Health; results first posted 2016-02-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sorafenib in Children and Young Adults With Recurrent or Progressive Low-Grade Astrocytomas. Trials, record NCT01338857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01338857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorafenib in Children and Young Adults With Recurrent or Progressive Low-Grade Astrocytomas
- NCT number
- NCT01338857
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- neurofibromatosis1 (NF1), Recurrent or Progressive Optic Pathway Gliomas (OPG), Recurrent or Progressive Low-grade Glioma
- Interventions
- Sorafenib (Nexavar)
- First posted
- 2011-04-20
- Last updated
- 2017-02-17
- Results first posted
- 2016-02-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate to Sorafenib | one year | To estimate the objective response rates to sorafenib in children and young adults with low-grade astrocytomas, including optic pathway gliomas. |
| Primary | Objective Response Rates | MRIs performed after every 3rd 28-day cycle and off-study | Determination of tumor response (CR, PR, SD) will be defined based on the comparison of the baseline MRI performed at study entry to the subsequent MRI which demonstrated best response. PR will be defined by a \>15% decrease in tumor volume, as measured by 3D volumetric analysis. |
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 | Response Rate to Sorafenib | one year | Study terminated and 1/12 participants completed and data was analyzed | participants | NUMBER |
| PRIMARY | Objective Response Rates | MRIs performed after every 3rd 28-day cycle and off-study | Study terminated and 1/12 participants completed and data was analyzed | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate to Sorafenib | Sorafenib (Nexavar) | 1 | participants | ||
| Objective Response Rates | Sorafenib (Nexavar) | 1 | 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 | Sorafenib (Nexavar) | 12 | |
| Overall Study | COMPLETED | Sorafenib (Nexavar) | 1 | |
| Overall Study | NOT COMPLETED | Sorafenib (Nexavar) | 11 |
Source ClinicalTrials.gov
Adverse events65
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 | ALT increase | Investigations | Sorafenib (Nexavar) | 5 | 12 | 6 |
| other | anal hemorrhage | Gastrointestinal disorders | Sorafenib (Nexavar) | 1 | 12 | 1 |
| other | anemia | Blood and lymphatic system disorders | Sorafenib (Nexavar) | 2 | 12 | 2 |
| other | anorexia | Metabolism and nutrition disorders | Sorafenib (Nexavar) | 1 | 12 | 1 |
| other | ascites | Gastrointestinal disorders | Sorafenib (Nexavar) | 1 | 12 | 1 |
| other | AST elevation | Investigations | Sorafenib (Nexavar) | 8 | 12 | 9 |
| other | blood in stool | Gastrointestinal disorders | Sorafenib (Nexavar) | 1 | 12 | 2 |
| other | cold symptoms (runny nose) | Respiratory, thoracic and mediastinal disorders | Sorafenib (Nexavar) | 1 | 12 | 1 |
| other | conjunctivitis | Eye disorders | Sorafenib (Nexavar) | 1 | 12 | 1 |
| other | constipation | Gastrointestinal disorders | Sorafenib (Nexavar) | 3 | 12 | 3 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib (Nexavar) | ||
| Total, other adverse events | Sorafenib (Nexavar) | 12 | 12 |
| Total, serious adverse events | Sorafenib (Nexavar) | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24351969 | DERIVED |
Source PubMed
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/NCT01338857
GET https://conductscience.org/api/trials/v1/NCT01338857/events?page=2