COMParing the efficacy sAfety & toleRability of paZopanib vs sunitinib
Research type
Research Study
Full title
Study VEG108844, a Study of Pazopanib versus Sunitinib in Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma
IRAS ID
3788
Contact name
Robert Hawkins
Sponsor organisation
GlaxoSmithKline UK Ltd
Eudract number
2008-002102-19.
Clinicaltrials.gov Identifier
Research summary
Research Summary
This is a randomized, open label, Phase III study to evaluate the efficacy and safety of pazopanib compared to sunitinib in subjects with advanced Renal Cell Cancer who have received no prior systemic therapy for advanced or metastatic renal cell cancer. Approximately 876 eligible subjects, 190 in the UK, will be stratified and randomized in a 1:1 ratio to receive either 800mg pazopanib to be administered once daily, orally in continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects are permitted to receive supportive care throughout the study when appropriate. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death. At the end of study treatment, subjects will be followed for survival until death or 3 years following the last subject enrolled into the study (whichever comes first). The primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. The secondary objectives are to evaluate overall survival, the objective response rate, time to response, duration of response, incidence and severity of adverse events, serious adverse events, other safety parameters, and assess quality of life. Safety and efficacy assessments will be regularly performed on all subjects. A Data Safety Monitoring Board will be established to monitor safety during the course of the study. Imaging data from all subjects will be centrally reviewed by an Independent Endpoint Review Committee. Archived tumour tissue will be examined for intra-tumoral biomarkers and genetic aberrations (e.g. mutations, amplifications and deletions).
Summary of Results
This is not completed yet, but we can provide a link once this is completed. UK Regulatory should be providing these links for the ClinicalTrials.gov
REC name
North West - Haydock Research Ethics Committee
REC reference
08/H1010/70
Date of REC Opinion
28 Oct 2008
REC opinion
Further Information Favourable Opinion