Adjuvant axitinib treatment of renal cancer: A randomized double-blind Phase 3 study of adjuvant axitinib vs. placebo in subjects at high risk of recurrent RCC (Protocol: AP311736)
The Study primary objective is to demonstrate an improvement in disease free survival (DFS) in patients at high risk of recurrent RCC randomly assigned to adjuvant axitinib (Arm A) vs. Placebo (Arm B) after nephrectomy.
Patients must be greater than or equal to 18 years old, newly-diagnosed RCC and treated by nephrectomy (complete or partial). with no evidence of macroscopic residual disease or metastatic disease.Also, patients must have histologically confirmed preponderant, defined as greater than 50%, clear cell RCC, with no previous systemic or anti-angiogenic treatment.At screening, no evidence of preexisting uncontrolled hypertension.
This is a prospective, randomized, double-blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily vs. placebo given for up to 3 years, with a minimum of 1 year. The dose may be increased or decreased depending on individual patient tolerance of axitinib. Patients will be randomized in a 1:1 ratio between axitinib vs placebo. Patients should begin study treatment within 7 days of randomization. Randomization will occur no sooner than 4 weeks post-nephrectomy and no later than 12 weeks post-nephrectomy. Patients will receive a starting dose of 5 mg of axitinib or placebo twice daily (BID) taken orally with or without food. Study drug will be taken beginning on Day 1 of the study. Doses should be taken approximately 12 hours apart.Patients who tolerate axitinib or placebo with no adverse events related to study drug above CTCAE Grade 2 for a consecutive 2 week period may have their dose increased by one dose level to a maximum of 10 mg BID (unless the patientï¿½s blood pressure is greater than 150/90 mm Hg or the patient is receiving antihypertensive medication). Patients experiencing drug reaction will undergo dose modification.
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