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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 28, 2003
Last Updated Date	January 25, 2011
Start Date ^ICMJE	August 2003
Estimated Primary Completion Date	February 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00065572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)
Official Title ^ICMJE	Not Provided
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Carcinoma, Renal Cell Kidney Neoplasms
Intervention ^ICMJE	Drug: ZD6126 Drug: Placebo
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Enrollment ^ICMJE	Not Provided
Estimated Completion Date	February 2004
Estimated Primary Completion Date	February 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00065572
Other Study ID Numbers ^ICMJE	D2820C00018, 6126IL/00018
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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