A Phase II Study of AZD4877 (a Novel Anti-Mitotic Agent) in Advanced Bladder Cancer - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00661609

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

Condition	Intervention	Phase
Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer	Drug: AZD4877	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AZD4877: Experimental Single agent AZD4877	Drug: AZD4877 IV, 25mg/weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661609

Show 36 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Gary Hudes, MD

Fox Chase Cancer Center

More Information

Additional Information:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca ( Jeffrey Skolnik, MD/Associate Medical Director )
Study ID Numbers:	D2782C00010
Study First Received:	April 16, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00661609 History of Changes
Health Authority:	Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; France: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Spain: Ministry of Health

Keywords provided by AstraZeneca:

Anti-mitotic
Eg5 Inhibitor
Kinesin Spindle Protein Inhibitor
Urothelial Cancer
Bladder Cancer
Renal Pelvis Cancer

Urethra Cancer
Ureter Cancer
Recurrent
Advanced
Stage IV

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Antimitotic Agents
Urologic Neoplasms

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Urologic Diseases
Therapeutic Uses
Urethral Neoplasms
Urethral Diseases
Ureteral Neoplasms
Pelvic Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009