A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
Trial ID or NCT#
NCT00661609
Status
NOT RECRUITING
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
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Sandy Srinivas
Medical oncologist,
Urologic specialist,
Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology
Contact us to find out if this trial is right for you.
Contact
Denise Haas
6507361252
View on ClinicalTrials.gov
