Back to resultsExploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)
Primary Purpose
Carcinoma, Renal Cell, Kidney Neoplasms
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ZD6126
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Kidney Cancer, Metastatic, Newly diagnosed renal cell carcinoma
Eligibility 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
Sites / Locations
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Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00065572
Brief Title
Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Suspended
Study Start Date
August 2003 (undefined)
Primary Completion Date
February 2004 (Anticipated)
Study Completion Date
February 2004 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Kidney Neoplasms
Keywords
Kidney Cancer, Metastatic, Newly diagnosed renal cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZD6126
Intervention Type
Drug
Intervention Name(s)
Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)
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