Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer
Status:
Completed
Trial end date:
2015-11-23
Target enrollment:
Participant gender:
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 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. >=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 as assessed by FACIT-Fatigue and
quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose
modification; and to evaluate safety.