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← Imfinzi: metastatic Urothelial carcinoma (neoadjuvant) after prior therapy

NCT00471536 · STUDY IN CONTEXT

Pazopanib in Treating Patients With Metastatic Urothelial Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria: A Complete Response (CR) requires the disappearance of all target lesions. A Partial Response (PR) requires \>=30% decrease in the sum of the longest diameter of target lesions from baseline measurement. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.

All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.

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secondary · POSTED

The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.

Eighteen of the 19 participants accrued to the study were evaluable for adverse events.

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secondary · POSTED

Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.

Source null

→

secondary · POSTED

The distribution of response durations will be estimated using the Kaplan-Meier method.

There were no responses.

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secondary · POSTED

The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.

All participants were evaluable for this endpoint.

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secondary · POSTED

The distribution of survival times will be estimated using the Kaplan-Meier method.

all participants were evaluable for this endpoint.

→

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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT00471536
trial label
Pazopanib in Treating Patients With Metastatic Urothelial Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0000
    source section id
    NCT00471536-om-0000
    source outcome index
    0
    endpoint
    Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])
    endpoint definition
    Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria: A Complete Response (CR) requires the disappearance of all target lesions. A Partial Response (PR) requires \>=30% decrease in the sum of the longest diameter of target lesions from baseline measurement. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
    time origin
    Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.
    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-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0001
    source section id
    NCT00471536-om-0001
    source outcome index
    1
    endpoint
    Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
    endpoint definition
    The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.
    time origin
    Every 4 weeks during treatment (maximum duration was 44 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eighteen of the 19 participants accrued to the study were evaluable for adverse events.
    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-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0002
    source section id
    NCT00471536-om-0002
    source outcome index
    2
    endpoint
    Confirmed Tumor Response (CR and PR)
    endpoint definition
    Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.
    time origin
    Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed 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-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0003
    source section id
    NCT00471536-om-0003
    source outcome index
    3
    endpoint
    Duration of Response
    endpoint definition
    The distribution of response durations will be estimated using the Kaplan-Meier method.
    time origin
    From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    There were no responses.
    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-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0004
    source section id
    NCT00471536-om-0004
    source outcome index
    4
    endpoint
    Time to Disease Progression
    endpoint definition
    The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.
    time origin
    Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants were evaluable for this endpoint.
    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-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0005
    source section id
    NCT00471536-om-0005
    source outcome index
    5
    endpoint
    Survival Time
    endpoint definition
    The distribution of survival times will be estimated using the Kaplan-Meier method.
    time origin
    Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    all participants were evaluable for this endpoint.
    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-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00471536-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00471536-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00471536-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00471536-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00471536-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00471536-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00471536
    harm key
    EG000
    source section id
    NCT00471536-ae
    event group key
    EG000
    event group label
    Treatment (Enzyme Inhibitor Therapy)
    serious affected
    3
    serious at risk
    18
    other affected
    18
    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