This is a phase II open label, single arm study evaluating treatment with pazopanib post
sunitinib treatment in 43 patients with metastatic renal cell carcinoma. Patients will
receive 800mg pazopanib per day given continuously until disease progression. Patients must
have received treatment with sunitinib and relapsed. Patient must have received prior
treatment with sunitinib for at least 12 weeks. Prior treatment with either temsirolimus or
everolimus in addition to sunitinib is allowed. The trial design uses a Simons two stage
design with an interim analysis planned after the first 15 evaluable patients. If 8 or more
of the first 15 evaluable patients remains disease free at 4 months, then a further 28
patients will be enrolled for a total of 43 metastatic renal cell cancer patients. It is
estimated that there could be up to 10% of patients dropping out and so to achieve the
required number of 43 evaluable patients the study will recruit up to 48 patients to ensure
that 43 complete if stage 2 is required.
Patients will receive treatment until disease progression, unacceptable toxicity or
withdrawal of patient consent. Response assessments will be carried out every 8 weeks until
disease progression. Safety assessments will be carried out every 4 weeks (plus a visit for
liver function tests after 2 weeks) for the first six months and then every eight weeks until
disease progression. A further safety assessment will be carried out 4 weeks after treatment
discontinuation.