| A Phase II Study of AZD4877 (a Novel Anti-Mitotic Agent) in Advanced Bladder Cancer |
| 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 |
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 |
|
| Phase II |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Objective Response Rate in patients with recurrent advanced urothelial cancer receiving 25 mg of AZD4877 once weekly, with a response of complete or partial as assessed by RECIST criteria [ Time Frame: RECIST criteria assessments performed 8 wks after study drug begins & every 8 wks thereafter until discontinuation of study drug. Confirmatory scans of Complete & Partial Response must be done at least 4 wks later or next scheduled scan 8 wks later ] [ Designated as safety issue: No ] |
To describe the efficacy of AZD4877 in terms of disease control rate [ Time Frame: Disease Control Rate : proportion of patients with Complete Response, Partial Response, or Stable Disease lasting at least 8 weeks from the first administration of study drug. ] [ Designated as safety issue: No ]
To describe the efficacy of AZD4877 in terms of duration of objective tumor response [ Time Frame: Duration of Response: among patients with Complete or Partial Response, time from first documentation of Complete or Partial Response, whichever occurs earlier, to progression or death ] [ Designated as safety issue: No ]
To describe the efficacy of AZD4877 in terms of progression-free survival and overall survival [ Time Frame: Progression-Free Survival: time from the first adminstration of study drug to disease progression or death. Overall Survival: time from the first administration of study drug to death ] [ Designated as safety issue: No ] |
Bladder Cancer
Transitional Cell Bladder Cancer
Urethra Cancer
Ureter Cancer
Renal Pelvis Cancer |
| Drug: AZD4877 |
|
|
|
| Recruiting |
| 50 |
| May 2008 |
| October 2009 |
Inclusion Criteria:
- Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
- 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
|
| Both |
| 18 Years and older |
| No |
|
|
| United States, Canada, Germany, Spain, United Kingdom |
|
| NCT00661609 |
| D2782C00010 |
|
| AstraZeneca |
|
| Principal Investigator: |
Gary Hudes, MD |
Fox Chase Cancer Center |
|
|
| AstraZeneca |
| October 2008 |
| April 16, 2008 |
| October 9, 2008 |
