BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.
Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month (cycle). Subjects will take a daily oral dose of BKM-120 at the dose level assigned. Subjects will have a clinic visit weekly during Cycle 1 and then on Day 1 and Day 15 of each cycle for blood tests and physical exam.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma
Time frame: 2 year
To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD
Time frame: 2 year
To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab
Time frame: 2 years
To determine whether the BKM-120 and bevacizumab combination at the MTD is associated with concomitant changes in angiokines and PI3K pathway members in plasma and tumor samples
Time frame: 2 years
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