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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00065572
First received: July 28, 2003
Last updated: January 25, 2011
Last verified: January 2011
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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:
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 May 22, 2013