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← recurrent Wilms Tumor

NCT03213665 · STUDY IN CONTEXT

Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A

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

Will evaluate other biomarkers as predictors of response to tazemetostat and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to tazemetostat treatment. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature.

Source null

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exploratory · NOT_POSTED

To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature.

Source null

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primary · POSTED

ORR will be defined as complete response + partial response and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.

Source null

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secondary · POSTED

Progression free survival will be defined as time from the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause. PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.

Source null

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secondary · POSTED

Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.

Source null

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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-wilms-tumor-recurrent-27f30be4
nct id
NCT03213665
trial label
Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A
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
5
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0003
    source section id
    NCT03213665-om-0003
    source outcome index
    3
    endpoint
    Biomarker Predictors of Response to Tazemetostat
    endpoint definition
    Will evaluate other biomarkers as predictors of response to tazemetostat and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to tazemetostat treatment. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature.
    time origin
    Up to 2 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-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0004
    source section id
    NCT03213665-om-0004
    source outcome index
    4
    endpoint
    Change in Tumor Genomics
    endpoint definition
    To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature.
    time origin
    Up to 2 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0000
    source section id
    NCT03213665-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    ORR will be defined as complete response + partial response and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Will be calculated as the percent of evaluable patients who are responders, and 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
    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-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0001
    source section id
    NCT03213665-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    Progression free survival will be defined as time from the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause. PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0002
    source section id
    NCT03213665-om-0002
    source outcome index
    2
    endpoint
    Percentage of Patients Experiencing Grade 3 or 4 Adverse Events
    endpoint definition
    Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
    time origin
    From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Tazemetostat)
    regimen
    Patients receive tazemetostat PO BID on days 1-28. 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
    NCT03213665-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Tazemetostat)
    regimen
    Patients receive tazemetostat PO BID on days 1-28. 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
    NCT03213665-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Tazemetostat)
    regimen
    Patients receive tazemetostat PO BID on days 1-28. 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
    NCT03213665-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-wilms-tumor-recurrent-27f30be4
    nct id
    NCT03213665
    harm key
    EG000
    source section id
    NCT03213665-ae
    event group key
    EG000
    event group label
    Treatment (Tazemetostat)
    serious affected
    12
    serious at risk
    20
    other affected
    16
    other at risk
    20
    frequency threshold
    0
    collection period
    From enrollment to 30 days after the end of treatment, up to 2 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. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
    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