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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZD4877

Single agent AZD4877

Group Type EXPERIMENTAL

AZD4877

Intervention Type DRUG

Intravenous (IV)25mg/weekly

Interventions

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AZD4877

Intravenous (IV)25mg/weekly

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No