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

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ClinicalTrials.gov Identifier: NCT00065572
Recruitment Status : Suspended
First Posted : July 31, 2003
Last Update Posted : January 26, 2011
Information provided by:

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
Carcinoma, Renal Cell Kidney Neoplasms Drug: ZD6126 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2003
Estimated Primary Completion Date : February 2004
Estimated Study Completion Date : February 2004

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U.S. FDA Resources

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065572

United States, California
Research Site
Los Angeles, California, United States
United States, Delaware
Research Site
Newark, Delaware, United States
United States, Florida
Research Site
Tampa, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, New Hampshire
Research Site
Lebanon, New Hampshire, United States
United States, New Jersey
Research Site
Hackensack, New Jersey, United States
United States, New York
Research Site
Bronx, New York, United States
Research Site
Rochester, New York, United States
United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
Sponsors and Collaborators

ClinicalTrials.gov Identifier: NCT00065572     History of Changes
Other Study ID Numbers: D2820C00018
First Posted: July 31, 2003    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Kidney Cancer
Newly diagnosed renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases