Clinical trial NCT00661609: A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Transitional Cell Bladder Cancer
Urethra Cancer
Ureter Cancer
Renal Pelvis Cancer
Keywords: Anti-mitotic
Eg5 Inhibitor
Kinesin Spindle Protein Inhibitor
Urothelial Cancer
Bladder Cancer
Renal Pelvis Cancer
Urethra Cancer
Ureter Cancer
Recurrent
Advanced
Stage IV
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
timeFrame: 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)
measure: Duration of Objective Tumor Response (OTR)
timeFrame: Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)
measure: Progression Free Survival (PFS)
timeFrame: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
measure: Overall Survival (OS)
timeFrame: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Research Site
state: California
city: San Bernardino
country: United States
facility: Research Site
state: California
city: Southington
country: United States
facility: Research Site
state: Connecticut
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Scarborough
country: United States
facility: Research Site
state: Maine
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Morristown
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Woonsocket
country: United States
facility: Research Site
state: Rhode Island
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
state: West Yorkshire
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Fox Chase Cancer Center
name: Gary Hudes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones R, Vuky J, Elliott T, Mead G, Arranz JA, Chester J, Chowdhury S, Dudek AZ, Muller-Mattheis V, Grimm MO, Gschwend JE, Wulfing C, Albers P, Li J, Osmukhina A, Skolnik J, Hudes G. Phase II study to assess the efficacy, safety and tolerability of the mitotic spindle kinesin inhibitor AZD4877 in patients with recurrent advanced urothelial cancer. Invest New Drugs. 2013 Aug;31(4):1001-7. doi: 10.1007/s10637-013-9926-y. Epub 2013 Jan 18.