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
To compare disease-free survival of patients treated with placebo to patients who are treated with pazopanib following nephrectomy for advanced renal cell carcinoma.
-Patients must have clear cell or predominant clear-cell renal cell carcinoma. -No evidence of metastasis on scans following surgery. -No prior adjuvant or neo-adjuvant treatment for renal cell carcinoma. -Must have adequate bone marrow, liver and kidney function as noted on labs. -No evidence of diarrhea. -BP must be controlled if history of hypertension with BP systolic less than 140 and diastolic less than 90mmHg. -Must be greater than 4 weeks post surgery and recovered from surgery. -Treatment must start within 12 weeks post surgery.
Patients will be randomized to receive pazopanib or placebo. This is a blinded study so neither patient nor the doctor will know which patient is receiving. Starting on Day 1 each patient will receive 800mg of drug or placebo once daily. Medication is taken 1 hour before or 2 hours after a meal. Patients will continue on study for 12 months as long as drug is tolerated without problems. Repeat scans are done at Week 20, Week 36 and Week 52 while on treatment. If disease is noted on scans during the one year, patients will be taken off study.
05/18/2013 04:02 AM