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: 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.

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-soft-tissue-sarcoma-pediatric
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: 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: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
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