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A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661609
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : January 12, 2011
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer Drug: AZD4877 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD4877
Single agent AZD4877
 Drug: AZD4877
Intravenous (IV)25mg/weekly


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) [ 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) ]
    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 Outcome Measures :
  1. Disease Control Rate (DCR) [ 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) ]
    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).

  2. Duration of Objective Tumor Response (OTR) [ 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) ]
    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)

  3. Progression Free Survival (PFS) [ Time Frame: 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.

  4. Overall Survival (OS) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
  • Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
  • Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting.
  • Ambulatory and capable of all selfcare more than 50% of waking hours

Exclusion Criteria:

  • Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication; 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
  • Inadequate bone marrow reserve
  • Inadequate liver function in the presence of liver metastases
  • Impaired renal function
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661609


Locations
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United States, California
Research Site
Palo Alto, California, United States
Research Site
San Bernardino, California, United States
United States, Connecticut
Research Site
Southington, Connecticut, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
Research Site
Marietta, Georgia, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Maine
Research Site
Scarborough, Maine, United States
United States, Michigan
Research Site
Ann Arbor, Michigan, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, New Jersey
Research Site
Hackensack, New Jersey, United States
Research Site
Morristown, New Jersey, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Research Site
Woonsocket, Rhode Island, United States
United States, Washington
Research Site
Seattle, Washington, United States
United States, West Virginia
Research Site
Morgantown, West Virginia, United States
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Canada
Research Site
Quebec, Canada
Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Dusseldorf, Germany
Research Site
Munchen, Germany
Research Site
Munster, Germany
Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
United Kingdom
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
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Gary Hudes, MD Fox Chase Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeffrey Skolnik, MD/Associate Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00661609    
Other Study ID Numbers: D2782C00010
First Posted: April 18, 2008    Key Record Dates
Results First Posted: January 12, 2011
Last Update Posted: January 12, 2011
Last Verified: December 2010
Keywords provided by AstraZeneca:
Anti-mitotic
Eg5 Inhibitor
Kinesin Spindle Protein Inhibitor
Urothelial Cancer
Bladder Cancer
Renal Pelvis Cancer
 Urethra Cancer
Ureter Cancer
Recurrent
Advanced
Stage IV
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Ureteral Neoplasms
Pelvic Neoplasms
Urethral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Ureteral Diseases
Urethral Diseases