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← Urethral Cancer

NCT00397488 · STUDY IN CONTEXT

Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

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. 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

Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria

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-urethral-cancer
nct id
NCT00397488
trial label
Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
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.
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
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer
    nct id
    NCT00397488
    outcome key
    om-0000
    source section id
    NCT00397488-om-0000
    source outcome index
    0
    endpoint
    Overall Objective Response
    endpoint definition
    Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria
    time origin
    2 years
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer
    nct id
    NCT00397488
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Sunitinib
    regimen
    Sunitinib in patients with metastatic urothelial carcinoma.
    analyzed count
    71
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397488-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer
    nct id
    NCT00397488
    harm key
    EG000
    source section id
    NCT00397488-ae
    event group key
    EG000
    event group label
    Sunitinib
    serious affected
    34
    serious at risk
    78
    other affected
    67
    other at risk
    78
    frequency threshold
    5
    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