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

Primary Purpose

Bladder Cancer, Transitional Cell Bladder Cancer, Urethra Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD4877
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Anti-mitotic, Eg5 Inhibitor, Kinesin Spindle Protein Inhibitor, Urothelial Cancer, Bladder Cancer, Renal Pelvis Cancer, Urethra Cancer, Ureter Cancer, Recurrent, Advanced, Stage IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AZD4877

Arm Description

Single agent AZD4877

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).

Secondary Outcome Measures

Disease Control Rate (DCR)
Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).
Duration of Objective Tumor Response (OTR)
Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)
Progression Free Survival (PFS)
Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.
Overall Survival (OS)
Time in weeks from the first administration of study drug to death.

Full Information

First Posted
April 16, 2008
Last Updated
December 13, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00661609
Brief Title
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

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD4877
Arm Type
Experimental
Arm Description
Single agent AZD4877
Intervention Type
Drug
Intervention Name(s)
AZD4877
Intervention Description
Intravenous (IV)25mg/weekly
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
Description
Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).
Time Frame
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 Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).
Time Frame
8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)
Title
Duration of Objective Tumor Response (OTR)
Description
Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)
Time Frame
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)
Title
Progression Free Survival (PFS)
Description
Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.
Time Frame
Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
Title
Overall Survival (OS)
Description
Time in weeks from the first administration of study drug to death.
Time Frame
Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Hudes, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Research Site
City
San Bernardino
State/Province
California
Country
United States
Facility Name
Research Site
City
Southington
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Scarborough
State/Province
Maine
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Woonsocket
State/Province
Rhode Island
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Dusseldorf
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Munster
Country
Germany
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Leeds
State/Province
West Yorkshire
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Southampton
Country
United Kingdom
Facility Name
Research Site
City
Surrey
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23329066
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.
Results Reference
derived

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

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