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← Malignant Mesothelioma

NCT01592383 · STUDY IN CONTEXT

Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma

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.

primary · POSTED

Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

The study was terminated early after the enrollment of two participants and the data were not collected.

→

secondary · POSTED

Progression free survival (PFS) defined as time from study enrollment until disease progression or death.

The study was terminated early after the enrollment of two participants and the data were not collected.

→

secondary · POSTED

Overall survival measured as the time from study enrollment until death.

The study was terminated early after the enrollment of two participants and the data were not collected.

→

secondary · POSTED

Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0

The study was terminated early after the enrollment of two participants and the data were not collected.

→

secondary · POSTED

Disease Control Rate - SD + PR + CR is calculated as the percentage of patients with either complete response (CR: disappearance of all target lesions), or with partial response (PR: at least 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease of an increase of at least 20% in the sum of the longest diameter of the target lesions taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions).

The study was terminated early after the enrollment of two participants and the data were not collected.

→

secondary · POSTED

EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients.

The study was terminated early after the enrollment of two participants and the data were not collected.

→

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
nct id
NCT01592383
trial label
Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0000
    source section id
    NCT01592383-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate
    endpoint definition
    Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    time origin
    1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was terminated early after the enrollment of two participants and the data were not collected.
    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
    nct id
    NCT01592383
    outcome key
    om-0001
    source section id
    NCT01592383-om-0001
    source outcome index
    1
    endpoint
    PFS
    endpoint definition
    Progression free survival (PFS) defined as time from study enrollment until disease progression or death.
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was terminated early after the enrollment of two participants and the data were not collected.
    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
    nct id
    NCT01592383
    outcome key
    om-0002
    source section id
    NCT01592383-om-0002
    source outcome index
    2
    endpoint
    OS
    endpoint definition
    Overall survival measured as the time from study enrollment until death.
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was terminated early after the enrollment of two participants and the data were not collected.
    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
    nct id
    NCT01592383
    outcome key
    om-0003
    source section id
    NCT01592383-om-0003
    source outcome index
    3
    endpoint
    Toxicity
    endpoint definition
    Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0
    time origin
    30 days from the last dose of study drug
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was terminated early after the enrollment of two participants and the data were not collected.
    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-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0004
    source section id
    NCT01592383-om-0004
    source outcome index
    4
    endpoint
    Disease Control Rate - SD + PR + CR
    endpoint definition
    Disease Control Rate - SD + PR + CR is calculated as the percentage of patients with either complete response (CR: disappearance of all target lesions), or with partial response (PR: at least 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease of an increase of at least 20% in the sum of the longest diameter of the target lesions taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions).
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was terminated early after the enrollment of two participants and the data were not collected.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0005
    source section id
    NCT01592383-om-0005
    source outcome index
    5
    endpoint
    EGFR Mutations Percentage
    endpoint definition
    EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients.
    time origin
    Baseline
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was terminated early after the enrollment of two participants and the data were not collected.
    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
    nct id
    NCT01592383
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01592383-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01592383-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01592383-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01592383-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01592383-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01592383-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma
    nct id
    NCT01592383
    harm key
    EG000
    source section id
    NCT01592383-ae
    event group key
    EG000
    event group label
    Treatment (Enzyme Inhibitor Therapy)
    serious affected
    0
    serious at risk
    2
    other affected
    1
    other at risk
    2
    frequency threshold
    0
    collection period
    1 year
    event definition
    An expected mild skin rash
    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