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← recurrent Malignant Mesothelioma

NCT02568449 · STUDY IN CONTEXT

Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent

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.

primary · POSTED

PFS will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).

Source null

→

secondary · POSTED

Number of participants with grade 3 or grade 4 for each type of toxicity encountered, using all toxicity evaluable patients.

Source null

→

secondary · POSTED

Overall survival will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).

Source null

→

secondary · POSTED

number of participants responded (complete response, partial response, stable disease, progressive disease, not evaluable) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)

Source null

→

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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT02568449
trial label
Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent
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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0000
    source section id
    NCT02568449-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    PFS will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
    time origin
    From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 4 months
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0001
    source section id
    NCT02568449-om-0001
    source outcome index
    1
    endpoint
    Incidence of Grade 3-4 Toxicity
    endpoint definition
    Number of participants with grade 3 or grade 4 for each type of toxicity encountered, using all toxicity evaluable patients.
    time origin
    Up to 1 year
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0002
    source section id
    NCT02568449-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Overall survival will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
    time origin
    Up to 1 year
    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-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0003
    source section id
    NCT02568449-om-0003
    source outcome index
    3
    endpoint
    Number of Participants Responded (Complete Response, Partial Response, Stable Disease, Progressive Disease, Not Evaluable)
    endpoint definition
    number of participants responded (complete response, partial response, stable disease, progressive disease, not evaluable) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
    time origin
    Up to 1 year
    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-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Nintedanib)
    regimen
    Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02568449-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Nintedanib)
    regimen
    Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02568449-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Nintedanib)
    regimen
    Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02568449-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Nintedanib)
    regimen
    Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02568449-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT02568449
    harm key
    EG000
    source section id
    NCT02568449-ae
    event group key
    EG000
    event group label
    Treatment (Nintedanib)
    serious affected
    12
    serious at risk
    20
    other affected
    20
    other at risk
    20
    frequency threshold
    5
    collection period
    Up to one year.
    event definition
    Source null
    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