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NCT02122172 · STUDY IN CONTEXT

Afatinib in Advanced Refractory Urothelial Cancer

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

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated at 3 months using the Kaplan-Meier method.

Analysis population included those in the main Phase II study

→

secondary · POSTED

Includes both complete responses (CR) and partial responses (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions (any pathological lymph nodes must have reduction in short axis to \<10 mm); Partial Response (PR) is defined as \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.

Analysis population includes those patients in the main Phase II study

→

secondary · POSTED

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated using the Kaplan-Meier method.

Analysis population includes patients from the main Phase II study

→

secondary · POSTED

Estimated using the Kaplan-Meier method.

Analysis population includes those in the main Phase II study

→

secondary · POSTED

These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was EGFR amplification.

The analysis sample included those in the main Phase II study. Two patients did not have a sample to analyze.

→

secondary · POSTED

These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was HER2 amplification.

Analysis population included those in the main Phase II study. Two patients did not have a sample to analyze

→

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-bladder-cancer-recurrent-a15d6191
nct id
NCT02122172
trial label
Afatinib in Advanced Refractory Urothelial Cancer
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
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0000
    source section id
    NCT02122172-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated at 3 months using the Kaplan-Meier method.
    time origin
    3 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis population included those in the main Phase II study
    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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0001
    source section id
    NCT02122172-om-0001
    source outcome index
    1
    endpoint
    Overall Response Rate
    endpoint definition
    Includes both complete responses (CR) and partial responses (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions (any pathological lymph nodes must have reduction in short axis to \<10 mm); Partial Response (PR) is defined as \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis population includes those patients in the main Phase II study
    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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0002
    source section id
    NCT02122172-om-0002
    source outcome index
    2
    endpoint
    Median Progression-free Survival (PFS ) Time
    endpoint definition
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated using the Kaplan-Meier method.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis population includes patients from the main Phase II study
    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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0003
    source section id
    NCT02122172-om-0003
    source outcome index
    3
    endpoint
    Median Overall Survival (OS) Time
    endpoint definition
    Estimated using the Kaplan-Meier method.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis population includes those in the main Phase II study
    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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0004
    source section id
    NCT02122172-om-0004
    source outcome index
    4
    endpoint
    EGFR Expression Status
    endpoint definition
    These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was EGFR amplification.
    time origin
    Baseline
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis sample included those in the main Phase II study. Two patients did not have a sample to analyze.
    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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0005
    source section id
    NCT02122172-om-0005
    source outcome index
    5
    endpoint
    HER2 Expression Status
    endpoint definition
    These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was HER2 amplification.
    time origin
    Baseline
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis population included those in the main Phase II study. Two patients did not have a sample to analyze
    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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Afatinib)
    regimen
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO laboratory biomarker analysis: Correlative studies
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02122172-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Afatinib)
    regimen
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO laboratory biomarker analysis: Correlative studies
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02122172-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Afatinib)
    regimen
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO laboratory biomarker analysis: Correlative studies
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02122172-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Afatinib)
    regimen
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO laboratory biomarker analysis: Correlative studies
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02122172-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Afatinib)
    regimen
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO laboratory biomarker analysis: Correlative studies
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02122172-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Afatinib)
    regimen
    Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. afatinib dimaleate: Given PO laboratory biomarker analysis: Correlative studies
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02122172-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    harm key
    EG000
    source section id
    NCT02122172-ae
    event group key
    EG000
    event group label
    Treatment (Afatinib) - Phase II Study
    serious affected
    11
    serious at risk
    23
    other affected
    23
    other at risk
    23
    frequency threshold
    5
    collection period
    From the initiation of treatment to 28 days after the last administration of trial drugs, up to 1 year
    event definition
    For the Other Adverse Events, the number of participants reported for each adverse event is an upper bound estimate.
    undenominated 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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT02122172
    harm key
    EG001
    source section id
    NCT02122172-ae
    event group key
    EG001
    event group label
    Treatment (Afatinib) - Molecularly Selected Cohort
    serious affected
    3
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    5
    collection period
    From the initiation of treatment to 28 days after the last administration of trial drugs, up to 1 year
    event definition
    For the Other Adverse Events, the number of participants reported for each adverse event is an upper bound estimate.
    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