- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00538772
An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Purpose:
The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression.
Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BC Cancer Agency - Centre for Southern Interior
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency - Vancouver
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Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer Agency - Vancouver Island
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol.
- Patients must provide written informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Biomarker
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Not applicable - blood tests/tissue specimen tests will be undertaken
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
Time Frame: Not available as study withdrawn on November 2010
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Not available as study withdrawn on November 2010
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Kollmannsberger, MD, BC Cancer Agency- Vancouver
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNC-001
- Biomarkers
- Metastatic Renal Cell
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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