Patient Preference Study Pazopanib Vs Sunitinib in Kidney Cancer
Research type
Research Study
Full title
A randomised double-blind cross-over patient preference study of pazopanib versus sunitinib in treatment naïve locally advanced or metastatic renal cell carcinoma
IRAS ID
40179
Contact name
Robert Hawkins
Sponsor organisation
Novartis Pharmaceuticals
Eudract number
2009-014249-10.
Clinicaltrials.gov Identifier
Research summary
This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 (at least 45 in the UK) eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. equal or less than 2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patient's stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire to evaluate fatigue and quality of life; to evaluate dose modifications and time to dose modification; and to evaluate safety.
REC name
North West - Haydock Research Ethics Committee
REC reference
10/H1010/11
Date of REC Opinion
4 May 2010
REC opinion
Further Information Favourable Opinion