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NCT02525692 · STUDY IN CONTEXT

Oral ONC201 in Adult Recurrent Glioblastoma

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

Progression-free survival rate at 6 months was defined as the percentage of patients who exhibit progression-free survival for \>6 months.

Note: In Arm B, one participant with recurrent H3 K27M-mutant glioblastoma and non-measurable disease experienced complete regression of enhancing lesions for \>1.5 years was censored from analysis due to use of anastrozole at baseline and throughout the study.

→

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-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT02525692
trial label
Oral ONC201 in Adult Recurrent Glioblastoma
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
6
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    outcome key
    om-0000
    source section id
    NCT02525692-om-0000
    source outcome index
    0
    endpoint
    Percent of Patients With Probability of Progression-Free Survival at 6 Months
    endpoint definition
    Progression-free survival rate at 6 months was defined as the percentage of patients who exhibit progression-free survival for \>6 months.
    time origin
    Progression-free survival assessments were conducted 6 months following treatment initiation.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Note: In Arm B, one participant with recurrent H3 K27M-mutant glioblastoma and non-measurable disease experienced complete regression of enhancing lesions for \>1.5 years was censored from analysis due to use of anastrozole at baseline and throughout the study.
    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-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A
    regimen
    Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences. Patients received 625 mg oral ONC201 once every 3 weeks.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02525692-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B
    regimen
    Patients with first recurrence of histologically confirmed WHO Grade IV glioma. Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02525692-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm C
    regimen
    Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02525692-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Arm D
    regimen
    Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed). Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02525692-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Arm E
    regimen
    Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02525692-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Arm F
    regimen
    Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status. Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02525692-om-0000#groups/OG005
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    harm key
    EG000
    source section id
    NCT02525692-ae
    event group key
    EG000
    event group label
    Arm A
    serious affected
    6
    serious at risk
    17
    other affected
    16
    other at risk
    17
    frequency threshold
    5
    collection period
    From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
    event definition
    Source null
    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-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    harm key
    EG001
    source section id
    NCT02525692-ae
    event group key
    EG001
    event group label
    Arm B
    serious affected
    1
    serious at risk
    19
    other affected
    17
    other at risk
    19
    frequency threshold
    5
    collection period
    From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    harm key
    EG002
    source section id
    NCT02525692-ae
    event group key
    EG002
    event group label
    Arm C
    serious affected
    1
    serious at risk
    8
    other affected
    5
    other at risk
    8
    frequency threshold
    5
    collection period
    From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    harm key
    EG003
    source section id
    NCT02525692-ae
    event group key
    EG003
    event group label
    Arm D
    serious affected
    11
    serious at risk
    30
    other affected
    29
    other at risk
    30
    frequency threshold
    5
    collection period
    From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    harm key
    EG004
    source section id
    NCT02525692-ae
    event group key
    EG004
    event group label
    Arm E
    serious affected
    1
    serious at risk
    3
    other affected
    2
    other at risk
    3
    frequency threshold
    5
    collection period
    From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02525692
    harm key
    EG005
    source section id
    NCT02525692-ae
    event group key
    EG005
    event group label
    Arm F
    serious affected
    1
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
    event definition
    Source null
    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