NCT01521715

First Line Pazopanib in Poor Risk Patients With Metastatic Renal Cell Carcinoma

A Single Arm Multicentre Study Evaluating Pazopanib in First-line Treatment of Poor-risk Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: iOMEDICO AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced renal cell carcinoma (RCC) are classified according to Memorial Sloan-Kettering Cancer Center (MSKCC) criteria in three risk-groups: favourable, intermediate and poor. To our knowledge there is only one study which examined the poor risk group (Hudes et al.), which led to the approval of temsirolimus in this population. However temsirolimus demonstrated a low response rate of 8.6% according to Response Evaluation Criteria In Solid Tumor (RECIST) criteria and a Progression free Survival (PFS) of 5.5 months and not all patients are suitable for temsirolimus treatment. Thus, in clinical routine high-risk patients are also treated with multi Tyrosinkinase Inhibitors (mTKI). To date, a prospective data acquisition and control of effectiveness of a mTKI-treatment in high-risk patients has not been conducted. Pazopanib was recently approved for the first-line treatment of advanced renal cell carcinoma in Europe and the USA. In the pivotal Phase III trial only nine patients in the pazopanib group were poor risk according to MSKCC risk criteria and no analysis of this subgroup was performed. Therefore further data in this group of patients with high medical need is needed. Currently there are no well-established predictive or prognostic biomarkers in RCC-mTKI treatment. This is one of the most important scientific questions in this field. In addition to the clinical endpoints in this study, the comprehensive biomarker program seeks to evaluate biomarker candidates and will help to learn more about the effects of pazopanib on the human organism.

Conditions

• Locally Advanced and/or Metastatic Renal Cell Carcinoma
• Carcinoma, Renal Cell
• Clear-cell Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pazopanib	800 mg (2x400mg) pazopanib per day should be taken orally without food at least one hour before or two hours after a meal until progression or occurrence of intolerable toxicity.

Timeline

• Start date: 2012-01-24
• Primary completion: 2017-06-30
• Completion: 2017-07-31
• First posted: 2012-01-31
• Last updated: 2017-08-23

Locations

8 sites across 1 country: Germany