32
Participants
Start Date
July 31, 2012
Primary Completion Date
April 30, 2014
Study Completion Date
April 30, 2014
BKM120
This is a single arm study, with a starting dose of BKM120 at 80mg/day. Two dose levels: 80mg/day and 100mg /day will be tested in the dose escalation phase. At least 3 patients will be enrolled at each dose level and at least 6 evaluable patients required to be treated at the recommended Phase II dose(RP2D)/MTD dose. After dose escalation the 80mg/day and the 100mg /day dose levels will be expanded to evaluate up to approximately a total of 15 patients each (if 100mg is determined as the RP2D/MTD).
Novartis Investigative Site, Beijing
Novartis Investigative Site, Guangzhou
Novartis Investigative Site, Guangzhou
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY