NCT00538772

An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Kim Chi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
OTHER	Not applicable - blood tests/tissue specimen tests will be undertaken	Not applicable - blood tests/tissue specimen tests will be undertaken

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-10-03
• Last updated: 2019-07-11

Locations

3 sites across 1 country: Canada