A Phase II, Single Arm, Single Agent, Multicentre, Adaptive 2-Stage Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD4877 Administered Weekly in Patients With Recurrent Advanced Urothelial Cancer
Sponsor study identifier
interventional
54
5 countries
36
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2008
Actual (reported)April 18, 2008
Actual (reported)May 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 2009
Actual (reported)December 2009
Actual (reported)January 12, 2011
Actual (reported)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)
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)
Duration of Objective Tumor Response (OTR)
Single agent AZD4877
Intravenous (IV)25mg/weekly
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
Palo Alto, California, United States
Research Site
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
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.
Gary Hudes, MD
Fox Chase Cancer Center
54 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2008
First Posted
April 18, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
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 from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
Overall Survival (OS)
Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
Contact the study team to confirm eligibility.
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
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Charlotte, North Carolina, United States
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Philadelphia, Pennsylvania, United States
Research Site
Woonsocket, Rhode Island, United States
Research Site
Seattle, Washington, United States
Research Site
Morgantown, West Virginia, United States
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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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
Primary Completion
May 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
January 12, 2011
Results First Posted
January 12, 2011
Record last verified: 2010-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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