Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)

Sponsor
AstraZeneca (Industry)
Overall Status
Suspended
CT.gov ID
NCT00065572
Collaborator
(none)
16
6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2003
Anticipated Primary Completion Date :
Feb 1, 2004
Anticipated Study Completion Date :
Feb 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Newly diagnosed metastatic renal cell carcinoma

    • Suitable for nephrectomy

    Exclusion Criteria:
    • Prior chemotherapy, biological therapy or radiation therapy for renal cell carcinoma or within the last 3 years for any other cancer

    • Significant cardiac event within 3 months of entry

    • Any history of coronary angioplasty or history of myocardial infarction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Los Angeles California United States
    2 Research Site Newark Delaware United States
    3 Research Site Tampa Florida United States
    4 Research Site Chicago Illinois United States
    5 Research Site Indianapolis Indiana United States
    6 Research Site Baltimore Maryland United States
    7 Research Site St. Louis Missouri United States
    8 Research Site Lebanon New Hampshire United States
    9 Research Site Hackensack New Jersey United States
    10 Research Site Bronx New York United States
    11 Research Site Rochester New York United States
    12 Research Site Cleveland Ohio United States
    13 Research Site Portland Oregon United States
    14 Research Site Philadelphia Pennsylvania United States
    15 Research Site Nashville Tennessee United States
    16 Research Site Salt Lake City Utah United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00065572
    Other Study ID Numbers:
    • D2820C00018
    • 6126IL/00018
    First Posted:
    Jul 31, 2003
    Last Update Posted:
    Jan 26, 2011
    Last Verified:
    Jan 1, 2011

    Study Results

    No Results Posted as of Jan 26, 2011