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← Diffuse Intrinsic Pontine Glioma (DIPG)

NCT02607124 · STUDY IN CONTEXT

A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays

Number of participants receiving investigational agent.

→

primary · POSTED

Number of Patients Alive at One Year

Number of enrolled and evaluable participants

→

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-diffuse-intrinsic-pontine-glioma-dipg
nct id
NCT02607124
trial label
A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT02607124
    outcome key
    om-0000
    source section id
    NCT02607124-om-0000
    source outcome index
    0
    endpoint
    Number of Adverse Events
    endpoint definition
    Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number of participants receiving investigational agent.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT02607124
    outcome key
    om-0001
    source section id
    NCT02607124-om-0001
    source outcome index
    1
    endpoint
    Number of Patients Alive at One Year
    endpoint definition
    Number of Patients Alive at One Year
    time origin
    1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number of enrolled and evaluable participants
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT02607124
    outcome key
    om-0000
    arm key
    OG000
    arm label
    RB+ High Grade Glioma
    regimen
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02607124-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT02607124
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Non-Biopsied Diffuse Instrinsic Pontine Glioma
    regimen
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02607124-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT02607124
    outcome key
    om-0001
    arm key
    OG000
    arm label
    RB+ High Grade Glioma
    regimen
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02607124-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT02607124
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Non-Biopsied Diffuse Instrinsic Pontine Glioma
    regimen
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02607124-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT02607124
    harm key
    EG000
    source section id
    NCT02607124-ae
    event group key
    EG000
    event group label
    Diffuse Intrinsic Pontine Glioma and High Grade Glioma
    serious affected
    4
    serious at risk
    10
    other affected
    10
    other at risk
    10
    frequency threshold
    5
    collection period
    2 years
    event definition
    Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
    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