TriangleNCT00661609 · STUDY IN CONTEXT
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder 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
Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).
Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).
Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)
Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.
Time in weeks from the first administration of study drug to death.
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-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- trial label
- A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder 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
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0000
- source section id
- NCT00661609-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
- endpoint definition
- Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).
- time origin
- 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
- 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-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0001
- source section id
- NCT00661609-om-0001
- source outcome index
- 1
- endpoint
- Disease Control Rate (DCR)
- endpoint definition
- Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).
- time origin
- 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
- 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-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0002
- source section id
- NCT00661609-om-0002
- source outcome index
- 2
- endpoint
- Duration of Objective Tumor Response (OTR)
- endpoint definition
- Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)
- time origin
- Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)
- analysis role
- secondary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0003
- source section id
- NCT00661609-om-0003
- source outcome index
- 3
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.
- time origin
- Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
- 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-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0004
- source section id
- NCT00661609-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival (OS)
- endpoint definition
- Time in weeks from the first administration of study drug to death.
- time origin
- Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
- 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-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0000
- arm key
- OG000
- arm label
- AZD4877
- regimen
- AZD4877 25 mg (Intravenous (IV), 25mg weekly)
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00661609-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0001
- arm key
- OG000
- arm label
- AZD4877
- regimen
- AZD4877 25 mg (Intravenous (IV), 25mg weekly)
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00661609-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0003
- arm key
- OG000
- arm label
- AZD4877
- regimen
- AZD4877 25 mg (Intravenous (IV), 25mg weekly)
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00661609-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- outcome key
- om-0004
- arm key
- OG000
- arm label
- AZD4877
- regimen
- AZD4877 25 mg (Intravenous (IV), 25mg weekly)
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00661609-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer-recurrent-b677a38b
- nct id
- NCT00661609
- harm key
- EG000
- source section id
- NCT00661609-ae
- event group key
- EG000
- event group label
- AZD4877
- serious affected
- 14
- serious at risk
- 41
- other affected
- 38
- other at risk
- 41
- 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