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← recurrent Childhood Ependymoma

NCT01462695 · STUDY IN CONTEXT

Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-ependymoma-pediatric-recurrent-72f73bfa
nct id
NCT01462695
trial label
Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
1
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT01462695
    outcome key
    om-0000
    source section id
    NCT01462695-om-0000
    source outcome index
    0
    endpoint
    Sustained Objective Response Rate
    endpoint definition
    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.
    time origin
    Up to 5 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT01462695
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Stratum A: Recurrent High Grade Glioma
    regimen
    Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01462695-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT01462695
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Stratum B: Recurrent Ependymoma
    regimen
    Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01462695-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT01462695
    harm key
    EG000
    source section id
    NCT01462695-ae
    event group key
    EG000
    event group label
    Stratum A: Recurrent High Grade Glioma
    serious affected
    14
    serious at risk
    16
    other affected
    8
    other at risk
    16
    frequency threshold
    0
    collection period
    Source null
    event definition
    One stratum A patient did not receive any study drug and was excluded from the summary of adverse events. SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs) or grade 5 adverse events resulting in death. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT01462695
    harm key
    EG001
    source section id
    NCT01462695-ae
    event group key
    EG001
    event group label
    Stratum B: Recurrent Ependymoma
    serious affected
    9
    serious at risk
    13
    other affected
    6
    other at risk
    13
    frequency threshold
    0
    collection period
    Source null
    event definition
    One stratum A patient did not receive any study drug and was excluded from the summary of adverse events. SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs) or grade 5 adverse events resulting in death. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice