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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer; Ureter Cancer; Urethra Cancer; Transitional Cell Bladder Cancer; Renal Pelvis Cancer

Treatments: Drug: AZD4877

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661609

D2782C00010

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

AZD4877

Experimental group

Description:

Single agent AZD4877

Treatment:

Drug: AZD4877