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NCT03233204 · STUDY IN CONTEXT

Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric

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 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.

exploratory · NOT_POSTED

Approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid will be explored. Descriptive analysis will be performed and will be summarized with simple summary statistics.

Source null

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primary · POSTED

A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors).

Source null

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secondary · POSTED

The Kaplan-Meier method will be used to estimate the 6 month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.

Source null

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secondary · POSTED

Percentage of patients experiencing treatment-related grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Source null

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secondary · POSTED

The mean (sd) of the AUC.

3 of the 6 enrolled patients had PK data available for analysis

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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
NCT03233204
trial label
Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric
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
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
5
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    outcome key
    om-0004
    source section id
    NCT03233204-om-0004
    source outcome index
    4
    endpoint
    Change in Tumor Genomic Profile
    endpoint definition
    Approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid will be explored. Descriptive analysis will be performed and will be summarized with simple summary statistics.
    time origin
    Cycle 5 day 1 to 4 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
    NCT03233204
    outcome key
    om-0000
    source section id
    NCT03233204-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate (Complete Response/Partial Response)
    endpoint definition
    A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors).
    time origin
    Up to 2 years from study entry
    analysis role
    primary
    reporting status
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    outcome key
    om-0001
    source section id
    NCT03233204-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    The Kaplan-Meier method will be used to estimate the 6 month PFS. 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
    Up to 6 months from study entry
    analysis role
    secondary
    reporting status
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    outcome key
    om-0002
    source section id
    NCT03233204-om-0002
    source outcome index
    2
    endpoint
    Percentage of Patients Experiencing Treatment-related Grade 3 or Higher Adverse Events
    endpoint definition
    Percentage of patients experiencing treatment-related grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
    time origin
    Up to 2 years from study entry
    analysis role
    secondary
    reporting status
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    outcome key
    om-0003
    source section id
    NCT03233204-om-0003
    source outcome index
    3
    endpoint
    Pharmacokinetics (PK) of Olaparib, Area Under the Curve (AUC)
    endpoint definition
    The mean (sd) of the AUC.
    time origin
    Up to day 8 of cycle 1
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    3 of the 6 enrolled patients had PK data available for 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
    NCT03233204
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Olaparib)
    regimen
    Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03233204-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Olaparib)
    regimen
    Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03233204-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Olaparib)
    regimen
    Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03233204-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Olaparib)
    regimen
    Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03233204-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ependymoma-pediatric-recurrent-72f73bfa
    nct id
    NCT03233204
    harm key
    EG000
    source section id
    NCT03233204-ae
    event group key
    EG000
    event group label
    Treatment (Olaparib)
    serious affected
    3
    serious at risk
    6
    other affected
    5
    other at risk
    6
    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 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    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