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NCT03526250 · STUDY IN CONTEXT

Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell C

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.

exploratory · NOT_POSTED

A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.

Source null

→

primary · POSTED

Defined as a patient who achieves a best response of partial response or complete response on the study. Confidence intervals will be constructed using the Wilson score interval method.

Three patients did not receive any protocol therapy and are excluded from this analysis.

→

secondary · POSTED

PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.

Three patients did not receive any protocol therapy and are excluded from this analysis.

→

secondary · POSTED

Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Three patients did not receive any protocol therapy and are excluded from this analysis.

→

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
NCT03526250
trial label
Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell C
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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03526250
    outcome key
    om-0003
    source section id
    NCT03526250-om-0003
    source outcome index
    3
    endpoint
    Changes in Tumor Genomics Over Time Through Evaluation of Circulating Tumor Deoxyribonucleic Acid
    endpoint definition
    A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
    time origin
    Baseline up to 5 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population 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
    NCT03526250
    outcome key
    om-0000
    source section id
    NCT03526250-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate
    endpoint definition
    Defined as a patient who achieves a best response of partial response or complete response on the study. Confidence intervals will be constructed using the Wilson score interval method.
    time origin
    From enrollment to the end of treatment, up to 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Three patients did not receive any protocol therapy and are excluded from this analysis.
    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-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03526250
    outcome key
    om-0001
    source section id
    NCT03526250-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.
    time origin
    At 6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Three patients did not receive any protocol therapy and are excluded from this analysis.
    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-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03526250
    outcome key
    om-0002
    source section id
    NCT03526250-om-0002
    source outcome index
    2
    endpoint
    Percentage of Patients Experiencing Grade 3 or Higher Adverse Events
    endpoint definition
    Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
    time origin
    From enrollment to 30 days after the end of treatment, up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Three patients did not receive any protocol therapy and are excluded from this analysis.
    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
    NCT03526250
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Palbociclib)
    regimen
    Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03526250-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03526250
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Palbociclib)
    regimen
    Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03526250-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03526250
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Palbociclib)
    regimen
    Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03526250-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03526250
    harm key
    EG000
    source section id
    NCT03526250-ae
    event group key
    EG000
    event group label
    Treatment (Palbociclib)
    serious affected
    8
    serious at risk
    20
    other affected
    19
    other at risk
    20
    frequency threshold
    0
    collection period
    Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years
    event definition
    Adverse event (AE) reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs/CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible and non-treated patients are excluded from reporting of AEs.
    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