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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00661609
First received: April 16, 2008
Last updated: December 13, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Bladder Cancer
Transitional Cell Bladder Cancer
Urethra Cancer
Ureter Cancer
Renal Pelvis Cancer
Drug: AZD4877
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Time in weeks from the first administration of study drug to death.


Enrollment: 54
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD4877
Single agent AZD4877
Drug: AZD4877
Intravenous (IV)25mg/weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661609

  Show 36 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Gary Hudes, MD Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Jeffrey Skolnik, MD/Associate Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00661609     History of Changes
Other Study ID Numbers: D2782C00010
Study First Received: April 16, 2008
Results First Received: July 19, 2010
Last Updated: December 13, 2010
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
France: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Spain: Ministry of Health

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:
Urinary Bladder Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014