Trial · NCT01462695
Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma
NCT01462695, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma. Trials, record NCT01462695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01462695
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma
- NCT number
- NCT01462695
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Childhood Cerebellar Anaplastic Astrocytoma, Childhood Cerebral Anaplastic Astrocytoma, Childhood Cerebral Astrocytoma, Childhood Infratentorial Ependymoma, Childhood Mixed Glioma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Subependymal Giant Cell Astrocytoma
- Interventions
- Diagnostic Laboratory Biomarker Analysis, Pharmacological Study, Sunitinib Malate
- First posted
- 2011-10-31
- Last updated
- 2015-08-27
- Results first posted
- 2015-03-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Objective Response Rate | Up to 5 years | Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sustained Objective Response Rate | Up to 5 years | One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response. | percentage of patients | 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 |
|---|---|---|---|---|---|
| Sustained Objective Response Rate | Stratum A: Recurrent High Grade Glioma | 0 | 95% Confidence Interval 0 to 19.8 | percentage of patients | |
| Sustained Objective Response Rate | Stratum B: Recurrent Ependymoma | 0 | 95% Confidence Interval 0 to 22.5 | percentage of patients |
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 | Stratum A: Recurrent High Grade Glioma | 17 | |
| Overall Study | STARTED | Stratum B: Recurrent Ependymoma | 13 | |
| Overall Study | COMPLETED | Stratum A: Recurrent High Grade Glioma | 0 | |
| Overall Study | COMPLETED | Stratum B: Recurrent Ependymoma | 0 | |
| Overall Study | NOT COMPLETED | Stratum A: Recurrent High Grade Glioma | 17 | |
| Overall Study | NOT COMPLETED | Stratum B: Recurrent Ependymoma | 13 |
Source ClinicalTrials.gov
Adverse events58
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 | Diarrhea | Gastrointestinal disorders | Stratum A: Recurrent High Grade Glioma | 0 | 16 | |
| other | Diarrhea | Gastrointestinal disorders | Stratum B: Recurrent Ependymoma | 1 | 13 | |
| other | Nausea | Gastrointestinal disorders | Stratum A: Recurrent High Grade Glioma | 1 | 16 | |
| other | Nausea | Gastrointestinal disorders | Stratum B: Recurrent Ependymoma | 0 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Stratum A: Recurrent High Grade Glioma | 1 | 16 | |
| other | Vomiting | Gastrointestinal disorders | Stratum B: Recurrent Ependymoma | 0 | 13 | |
| other | Fatigue | General disorders | Stratum A: Recurrent High Grade Glioma | 1 | 16 | |
| other | Fatigue | General disorders | Stratum B: Recurrent Ependymoma | 0 | 13 | |
| other | Alanine aminotransferase increased | Investigations | Stratum A: Recurrent High Grade Glioma | 1 | 16 | |
| other | Alanine aminotransferase increased | Investigations | Stratum B: Recurrent Ependymoma | 0 | 13 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum A: Recurrent High Grade Glioma | ||
| Total, all-cause mortality | Stratum B: Recurrent Ependymoma | ||
| Total, other adverse events | Stratum A: Recurrent High Grade Glioma | 8 | 16 |
| Total, other adverse events | Stratum B: Recurrent Ependymoma | 6 | 13 |
| Total, serious adverse events | Stratum A: Recurrent High Grade Glioma | 14 | 16 |
| Total, serious adverse events | Stratum B: Recurrent Ependymoma | 9 | 13 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Stratum A: Recurrent High Grade Glioma vs Stratum B: Recurrent Ependymoma: serious adverse events |
Source 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/NCT01462695
GET https://conductscience.org/api/trials/v1/NCT01462695/events?page=2