A Phase 2 interventional study of AZD4877 in Bladder Cancer, Transitional Cell Bladder Cancer and Urethra Cancer, sponsored by AstraZeneca. Completed at 36 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-12.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single agent AZD4877
Drug: AZD4877
Intravenous (IV)25mg/weekly
Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
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 frame: 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)
Disease Control Rate (DCR)
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 frame: 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)
Duration of Objective Tumor Response (OTR)
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 frame: 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)
Progression Free Survival (PFS)
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 frame: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
Overall Survival (OS)
Time in weeks from the first administration of study drug to death.
Time frame: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
Patients were recruited at 23 study sites in 5 countries: United States (7 centers), United Kingdom (6 centers), Germany (5 centers), Canada (3 centers), and Spain (2 centers) between 29 May 2008 and 11 January 2010. 54 participants were enrolled into the study of which 41 participants received at least one dose of study medication.
| Milestone | AZD4877 |
|---|---|
| Started | 41 |
| Completed | 0 |
| Not completed | 41 |
| Withdrew: Adverse event | 4 |
| Withdrew: Death | 20 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Pi decision | 1 |
| Withdrew: Survival follow up stage discontinued | 11 |
| Withdrew: Disease progression | 3 |
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).
| Percengate of participants | AZD4877 |
|---|---|
| Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) | 2.6 |
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).
| Percentage of participants | AZD4877 |
|---|---|
| Disease Control Rate (DCR) | 20.5 |
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)
Results for this outcome have not been posted.
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.
| Weeks | AZD4877 |
|---|---|
| Progression Free Survival (PFS) | 7.3 (0 to 44) |
Time in weeks from the first administration of study drug to death.
| Weeks | AZD4877 |
|---|---|
| Overall Survival (OS) | 23.1 (1.3 to 48.1) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZD4877 | — | 14/41 (34.1%) | 38/41 (92.7%) |
| Event | AZD4877 |
|---|---|
| Urinary Tract InfectionInfections and infestations | 2/41 |
| DehydrationMetabolism and nutrition disorders | 2/41 |
| LeukopeniaBlood and lymphatic system disorders | 1/41 |
| NeutropeniaBlood and lymphatic system disorders | 1/41 |
| Acute Myocardial InfarctionCardiac disorders | 1/41 |
| Cardiac Failure CongestiveCardiac disorders | 1/41 |
| Ventricular ArrhythmiaCardiac disorders | 1/41 |
| Abdominal PainGastrointestinal disorders | 1/41 |
| Chest PainGeneral disorders | 1/41 |
| DeathGeneral disorders | 1/41 |
| Event | AZD4877 |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 23/41 |
| FatigueGeneral disorders | 13/41 |
| AnaemiaBlood and lymphatic system disorders | 11/41 |
| NauseaGastrointestinal disorders | 11/41 |
| Urinary Tract InfectionInfections and infestations | 11/41 |
| ConstipationGastrointestinal disorders | 8/41 |
| VomitingGastrointestinal disorders | 8/41 |
| LeukopeniaBlood and lymphatic system disorders | 7/41 |
| PyrexiaGeneral disorders | 7/41 |
| AnorexiaMetabolism and nutrition disorders | 7/41 |
| Age, Customized(Participants) | AZD4877 |
|---|---|
| >=18 - <65 Years | 17 |
| >=65 - <75 Years | 19 |
| >=75 Years | 5 |
| Sex: Female, Male(Participants) | AZD4877 |
|---|---|
| Female | 11 |
| Male | 30 |
| Race/Ethnicity, Customized(participants) | AZD4877 |
|---|---|
| White | 40 |
| Black and African | 1 |
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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