NCT01070186

Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sunitinib	50mg/day for 4 weeks
OTHER	Tumor biopsy	Conducted prior to administration of sunitinib therapy
PROCEDURE	Nephrectomy	Nephrectomy 2-4 weeks after last dose of Sunitinib
OTHER	Biomarkers	Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery. Biomarker evaluation of tissue prior to 4 week administration of Sunitinib

Timeline

• Start date: 2010-10-01
• First posted: 2010-02-17
• Last updated: 2012-07-31