NCT01361113

Neoadjuvant Pazopanib in Renal Cell Carcinoma

Neoadjuvant Pazopanib: A Phase II Study to Evaluate the Effect on Disease Response and Recurrence and to Establish Predictive Biomarkers of Drug Activity in Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a single arm phase II clinical trial of 8 weeks of daily, oral neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically confirmed localized renal cell carcinoma (RCC).

Detailed description

The primary objective of this study is to determine the objective response rate Complete Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 8 weeks as defined via Response Evaluation Criteria in Solid Tumors (RECIST1.1). The investigators will also estimate the recurrence free survival (RFS), specifically the 1 and 2 year rates, with recurrence defined via RECIST1.1, and characterize the safety issues. Finally, this study also includes a number of exploratory analyses designed to evaluate potential correlations between RFS and; serum levels of cytokine and angiogenesis factor (CAF).

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pazopanib	800 mg orally once daily for 8 weeks, prior to nephrectomy

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-01-07
• Completion: 2017-02-15
• First posted: 2011-05-26
• Last updated: 2018-04-25
• Results posted: 2017-05-10

Locations

2 sites across 1 country: United States