The primary endpoint of ongoing Stu

The primary endpoint of ongoing Study 6201 is the incidence and severity of diarrhea. The original protocol dated 11/19/14 had an accrual goal of 70 patients. Patients were treated with neratinib 240 mg daily and also received loperamide at the following schedule: Initial dose of 4 mg (2 tablets/capsules) with the first dose of neratinib followed by 2 mg (1 tablet/capsule) every four hours for the first 3 days (Day 1 = 16mg/day; Days 2-3 = 12 mg/day). After the first 3 days, loperamide 2mg every 6-8 hours through the first 2 cycles of therapy (Days 4-56 = 6-8 mg/day) from start of neratinib.