Status:
COMPLETED
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Bladder Cancer
Transitional Cell Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 divisio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00661609
Start Date
May 1 2008
End Date
December 1 2009
Last Update
January 12 2011
Active Locations (36)
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1
Research Site
Palo Alto, California, United States
2
Research Site
San Bernardino, California, United States
3
Research Site
Southington, Connecticut, United States
4
Research Site
Miami, Florida, United States