This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part. Once the MTD has been defined, the MTD expansion part will be opened for enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)
Nashville, Tennessee, United States
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Rotterdam, Netherlands
Novartis Investigative Site
Rotterdam, Netherlands
Maximum Tolerated Dose (MTD) of BKM120
Time frame: throughout the study
Safety and tolerability of BKM120
Time frame: throughout the study
Pharmacokinetics of BKM120
Time frame: throughout the study
Changes in tumor metabolic activity
Time frame: throughout the study
Pharmacodynamics of BKM120
Time frame: throughout the study
Clinical tumor response in patients with tumors that show PI3K pathway activation
Time frame: throughout the study
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Novartis Investigative Site
Barcelona, Catalonia, Spain