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
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.
The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.
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.
The distribution of response durations will be estimated using the Kaplan-Meier method.
The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.
The distribution of survival times will be estimated using the Kaplan-Meier method.
Reported safety
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Triangle