Trial · NCT00661609
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
NCT00661609, Phase 2, Completed, AstraZeneca; results first posted 2011-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer. Trials, record NCT00661609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661609
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
- NCT number
- NCT00661609
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Bladder Cancer, Transitional Cell Bladder Cancer, Urethra Cancer, Ureter Cancer, Renal Pelvis Cancer
- Interventions
- AZD4877
- First posted
- 2008-04-18
- Last updated
- 2011-01-12
- Results first posted
- 2011-01-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) | 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks) | 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). |
| Secondary | Disease Control Rate (DCR) | 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks) | 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). |
| Secondary | Duration of Objective Tumor Response (OTR) | 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) | 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) |
| Secondary | Progression Free Survival (PFS) | Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) | 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. |
| Secondary | Overall Survival (OS) | Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) | Time in weeks from the first administration of study drug to death. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) | 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks) | 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). | Percengate of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks) | 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). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Tumor Response (OTR) | 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) | Time in weeks | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) | 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). | Weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) | 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). | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) | AZD4877 | 2.6 | Percengate of participants | ||
| Disease Control Rate (DCR) | AZD4877 | 20.5 | Percentage of participants | ||
| Progression Free Survival (PFS) | AZD4877 | 7.3 | Full Range 0 to 44 | Weeks | |
| Overall Survival (OS) | AZD4877 | 23.1 | Full Range 1.3 to 48.1 | Weeks |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD4877 | 41 | |
| Overall Study | COMPLETED | AZD4877 | 0 | |
| Overall Study | NOT COMPLETED | AZD4877 | 41 |
Source ClinicalTrials.gov
Adverse events47
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | AZD4877 | 23 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | AZD4877 | 11 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | AZD4877 | 7 | 41 | |
| other | Nausea | Gastrointestinal disorders | AZD4877 | 11 | 41 | |
| other | Constipation | Gastrointestinal disorders | AZD4877 | 8 | 41 | |
| other | Vomiting | Gastrointestinal disorders | AZD4877 | 8 | 41 | |
| other | Abdominal Pain | Gastrointestinal disorders | AZD4877 | 5 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD4877 | 5 | 41 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | AZD4877 | 3 | 41 | |
| other | Abdominal Distension | Gastrointestinal disorders | AZD4877 | 3 | 41 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD4877 | ||
| Total, other adverse events | AZD4877 | 38 | 41 |
| Total, serious adverse events | AZD4877 | 14 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23329066 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00661609
GET https://conductscience.org/api/trials/v1/NCT00661609/events?page=2