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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4877 | Experimental | Single agent AZD4877 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4877 | Drug | Intravenous (IV)25mg/weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hudes, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Palo Alto | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23329066 | Derived | Jones R, Vuky J, Elliott T, Mead G, Arranz JA, Chester J, Chowdhury S, Dudek AZ, Muller-Mattheis V, Grimm MO, Gschwend JE, Wulfing C, Albers P, Li J, Osmukhina A, Skolnik J, Hudes G. Phase II study to assess the efficacy, safety and tolerability of the mitotic spindle kinesin inhibitor AZD4877 in patients with recurrent advanced urothelial cancer. Invest New Drugs. 2013 Aug;31(4):1001-7. doi: 10.1007/s10637-013-9926-y. Epub 2013 Jan 18. |
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Following enrolment there was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with AZD4877.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD4877 | AZD4877 25 mg (Intravenous (IV), 25mg weekly) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 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 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 from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) |
| San Bernardino |
| California |
| United States |
| Research Site | Southington | Connecticut | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Marietta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Scarborough | Maine | United States |
| Research Site | Ann Arbor | Michigan | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Hackensack | New Jersey | United States |
| Research Site | Morristown | New Jersey | United States |
| Research Site | New York | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Woonsocket | Rhode Island | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Morgantown | West Virginia | United States |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Berlin | Germany |
| Research Site | Dresden | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | München | Germany |
| Research Site | Münster | Germany |
| Research Site | Barcelona | Spain |
| Research Site | Madrid | Spain |
| Research Site | Leeds | West Yorkshire | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Southampton | United Kingdom |
| Research Site | Surrey | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD4877 | AZD4877 25 mg (Intravenous (IV), 25mg weekly) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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). | Posted | Number | Percengate of participants | 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks) |
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| Secondary | 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). | 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). | Posted | Number | Percentage of participants | 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | 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) | Not Posted | Number | Time in weeks | 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) | ||||||||||||||||||||||||||||||
| Secondary | 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. | 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). | Posted | Median | Full Range | Weeks | Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) |
|
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| Secondary | Overall Survival (OS) | Time in weeks from the first administration of study drug to death. | 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). | Posted | Median | Full Range | Weeks | Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD4877 | AZD4877 25 mg (Intravenous (IV), 25mg weekly) | 14 | 41 | 38 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Ventricular Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Narcotic Intoxication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Oral Candidiasis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Weight Decreased | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014523 | Urethral Neoplasms |
| D014516 | Ureteral Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014522 | Urethral Diseases |
| D014515 | Ureteral Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C568512 | N-(3-aminopropyl)-N-(1-(5-benzyl-3-methyl-4-oxo-(1,2)thiazolo(5,4-d)pyrimidin-6-yl)-2-methylpropyl)-4-methylbenzamide |
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|---|---|
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