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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

Tracking Information
First Submitted Date  ICMJE April 16, 2008
First Posted Date  ICMJE April 18, 2008
Results First Submitted Date  ICMJE July 19, 2010
Results First Posted Date  ICMJE January 12, 2011
Last Update Posted Date January 12, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
Objective Response Rate in patients with recurrent advanced urothelial cancer receiving 25 mg of AZD4877 once weekly, with a response of complete or partial as assessed by RECIST criteria [ Time Frame: RECIST criteria assessments performed 8 wks after study drug begins & every 8 wks thereafter until discontinuation of study drug. Confirmatory scans of Complete & Partial Response must be done at least 4 wks later or next scheduled scan 8 wks later ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
  • 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).
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
  • To describe the efficacy of AZD4877 in terms of disease control rate [ Time Frame: Disease Control Rate : proportion of patients with Complete Response, Partial Response, or Stable Disease lasting at least 8 weeks from the first administration of study drug. ]
  • To describe the efficacy of AZD4877 in terms of duration of objective tumor response [ Time Frame: Duration of Response: among patients with Complete or Partial Response, time from first documentation of Complete or Partial Response, whichever occurs earlier, to progression or death ]
  • To describe the efficacy of AZD4877 in terms of progression-free survival and overall survival [ Time Frame: Progression-Free Survival: time from the first adminstration of study drug to disease progression or death. Overall Survival: time from the first administration of study drug to death ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Transitional Cell Bladder Cancer
  • Urethra Cancer
  • Ureter Cancer
  • Renal Pelvis Cancer
Intervention  ICMJE Drug: AZD4877
Intravenous (IV)25mg/weekly
Study Arms  ICMJE Experimental: AZD4877
Single agent AZD4877
Intervention: Drug: AZD4877
Publications * Jones R, Vuky J, Elliott T, Mead G, Arranz JA, Chester J, Chowdhury S, Dudek AZ, Müller-Mattheis V, Grimm MO, Gschwend JE, Wülfing 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2010)
54
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)
50
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661609
Other Study ID Numbers  ICMJE D2782C00010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jeffrey Skolnik, MD/Associate Medical Director, AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary Hudes, MD Fox Chase Cancer Center
PRS Account AstraZeneca
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP