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← recurrent Malignant Mesothelioma

NCT01861301 · STUDY IN CONTEXT

Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma

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

Fisher's exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar's test will be used for binary markers.

Source null

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exploratory · NOT_POSTED

Will be evaluated by Spearman's rank correlation coefficient.

Source null

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primary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Note: Study terminated for futility due to insufficient number of objective responders in first stage.

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secondary · POSTED

Grade 3 or higher AE of any type, regardless of attribution.

Source null

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secondary · POSTED

Analyzed using the Kaplan-Meier method.

Source null

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secondary · POSTED

Time to disease progression or death from any cause. Analyzed using the Kaplan-Meier method.

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-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT01861301
trial label
Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0004
    source section id
    NCT01861301-om-0004
    source outcome index
    4
    endpoint
    Change in Baseline Levels of Continuous or Ordinal Markers (e.g., Serum HGF/MET IHC) Between Responders and Non-responders
    endpoint definition
    Fisher's exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar's test will be used for binary markers.
    time origin
    Baseline to 1 year
    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-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0005
    source section id
    NCT01861301-om-0005
    source outcome index
    5
    endpoint
    Change in Serum HGF or MET IHC and Tumor Size Change (Percent Reduction in Sum of Longest Diameters)
    endpoint definition
    Will be evaluated by Spearman's rank correlation coefficient.
    time origin
    Baseline to 1 year
    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-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0000
    source section id
    NCT01861301-om-0000
    source outcome index
    0
    endpoint
    Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    endpoint definition
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    time origin
    Up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Note: Study terminated for futility due to insufficient number of objective responders in first stage.
    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
    NCT01861301
    outcome key
    om-0001
    source section id
    NCT01861301-om-0001
    source outcome index
    1
    endpoint
    Incidence of Adverse Events, Graded Per NCI CTCAE Version 4
    endpoint definition
    Grade 3 or higher AE of any type, regardless of attribution.
    time origin
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0002
    source section id
    NCT01861301-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Analyzed using the Kaplan-Meier method.
    time origin
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0003
    source section id
    NCT01861301-om-0003
    source outcome index
    3
    endpoint
    Progression-free Survival
    endpoint definition
    Time to disease progression or death from any cause. Analyzed using the Kaplan-Meier method.
    time origin
    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-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Tivantinib)
    regimen
    Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01861301-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Tivantinib)
    regimen
    Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01861301-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Tivantinib)
    regimen
    Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01861301-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Tivantinib)
    regimen
    Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01861301-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT01861301
    harm key
    EG000
    source section id
    NCT01861301-ae
    event group key
    EG000
    event group label
    Treatment (Tivantinib)
    serious affected
    3
    serious at risk
    18
    other affected
    17
    other at risk
    18
    frequency threshold
    0
    collection period
    Source null
    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