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NCT00065572 Clinical Trial

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

Carcinoma, Renal Cell Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00065572
Other study ID # D2820C00018
Secondary ID 6126IL/00018
Status Suspended
Phase Phase 2
First received July 28, 2003
Last updated January 25, 2011
Start date August 2003
Est. completion date February 2004

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Suspended
Enrollment 0
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ZD6126

• Placebo

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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

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