This study is being conducted to determine the safety and maximally tolerated dose of PX-866 when given orally on two different schedules: daily on days 1-5 and 8-12 of a 28 day cycle and daily on days 1-28 of a 28 day cycle.
PX-866 is a targeted inhibitor of PI-3K. This study is being conducted to determine the maximally tolerated dose of PX-866 when given orally on two different schedules: daily on days 1-5 and 8-12 of a 28 day cycle and daily on days 1-28 of a 28 day cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Oral solution, dose escalation, once per day on days 1 to 5 and 8 to 12 or days 1-28 of a 28 day cycle, until progression or development of unacceptable toxicity
University of Colorado Health Sciences Center
Aurora, Colorado, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Determine the MTD of PX-866
Time frame: 28 days
Evaluate the safety profile of PX-866
Time frame: 28 days
Evaluate pharmacodynamic measures of the effects of PX-866 on the phosphatidylinositol-3 kinase (PI-3K) pathway and related tumor markers.
Time frame: 28 days
Determine the PK profile of PX-866.
Time frame: 28 days
Evaluate the anti-tumor activity of PX-866 in patients with advanced malignancies.
Time frame: 56 days
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