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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00065572
First received: July 28, 2003
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Study Start Date: August 2003
Estimated Study Completion Date: February 2004
Estimated Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065572

Locations
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
AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00065572     History of Changes
Other Study ID Numbers: D2820C00018, 6126IL/00018
Study First Received: July 28, 2003
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014