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

Completed · Phase 2

Conditions studied: Bladder Cancer, Transitional Cell Bladder Cancer, Urethra Cancer, Ureter Cancer, Renal Pelvis Cancer

In brief

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

Key facts

Study ID

NCT00661609

Run by

AstraZeneca

People needed

54

Starts

2008-05-01

Expected to finish

2009-12-01

Last updated by the study team

2011-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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