efficacy & safety of pazopanib as adjuvant therapy in renal cancer
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of pazopanib as adjuvant therapy for subjects with localized or locally advanced RCC following nephrectomy
IRAS ID
60742
Contact name
Manon Pillai
Contact email
Eudract number
2010-020965-26
Duration of Study in the UK
20 years, 1 months, days
Research summary
Renal cell carcinoma (RCC) accounts for 85-90% of all kidney cancers and is a deadly disease that still has no cure. For patients with localized disease, i.e. without metastasis , the current standard treatment is surgical resection of the primary tumor via partial or radical nephrectomy. Unfortunately, approximately 20-40% of these patients will eventually develop local recurrence or distal metastasis after nephrectomy.
At present, no adjuvant therapy has been established that can effectively prevent disease recurrence or improve disease-free survival for patients with localized disease following nephrectomy.VEG113387 is a Phase III, randomized, double-blind, placebo-controlled global study to evaluate pazopanib as an adjuvant therapy for subjects with localized or locally advanced RCC who are at risk of developing disease recurrence following nephrectomy and will evaluate and compare pazopanib and placebo for Disease Free Survival.
The study comprises of three study periods: the Screening Period, the Study Treatment Period; when eligible subjects will be randomized in a 1:1 ratio to receive blinded study treatment of either pazopanib 800mg or matching placebo daily for 12 months; and the disease free /overall survival follow up period when patients will be assessed every 6 months for years 2-5 then every 12 months until study completion defined as the target number of death events for the final overall survival analysis. The study will enroll 1500 patients overall, a minimum of 40 from the UK.
REC name
North West - Haydock Research Ethics Committee
REC reference
10/H1010/58
Date of REC Opinion
22 Oct 2010
REC opinion
Favourable Opinion