A Phase I Study of BKM120 in Adult Chinese Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Advanced Breast Cancer, Advanced Carcinomas With Squamous Cell Histology
Interventions
DRUG

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).

Trial Locations (3)

100021

Novartis Investigative Site, Beijing

510030

Novartis Investigative Site, Guangzhou

510060

Novartis Investigative Site, Guangzhou

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY