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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00661609
Other study ID # D2782C00010
Secondary ID
Status Completed
Phase Phase 2
First received April 16, 2008
Last updated December 13, 2010
Start date May 2008
Est. completion date December 2009

Study information

Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesFrance: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationSpain: Ministry of Health
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
AZD4877
Intravenous (IV)25mg/weekly

Locations

Country Name City State
Canada Research Site Halifax Nova Scotia
Canada Research Site Montreal Quebec
Canada Research Site Quebec
Canada Research Site Toronto Ontario
Canada Research Site Vancouver British Columbia
Germany Research Site Berlin
Germany Research Site Dresden
Germany Research Site Dusseldorf
Germany Research Site Munchen
Germany Research Site Munster
Spain Research Site Barcelona
Spain Research Site Madrid
United Kingdom Research Site Glasgow
United Kingdom Research Site Leeds West Yorkshire
United Kingdom Research Site London
United Kingdom Research Site Manchester
United Kingdom Research Site Southampton
United Kingdom Research Site Surrey
United States Research Site Ann Arbor Michigan
United States Research Site Atlanta Georgia
United States Research Site Charlotte North Carolina
United States Research Site Chicago Illinois
United States Research Site Hackensack New Jersey
United States Research Site Marietta Georgia
United States Research Site Miami Florida
United States Research Site Minneapolis Minnesota
United States Research Site Morgantown West Virginia
United States Research Site Morristown New Jersey
United States Research Site New York New York
United States Research Site Palo Alto California
United States Research Site Philadelphia Pennsylvania
United States Research Site San Bernardino California
United States Research Site Scarborough Maine
United States Research Site Seattle Washington
United States Research Site Southington Connecticut
United States Research Site Woonsocket Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks) No
Secondary 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). 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks) No
Secondary 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) 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) No
Secondary 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. Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) No
Secondary Overall Survival (OS) Time in weeks from the first administration of study drug to death. Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) No
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