This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Zurich, Switzerland
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
Time frame: 21 day cycles
To characterize the safety and tolerability of LEQ506 treatment
Time frame: 21 day cycles
To characterize the pharmacokinetics of LEQ506
Time frame: 21 day cycles
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
Time frame: 21 day cycles
Tumor response
Time frame: every 6 weeks
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Novartis Investigative Site
Oxford, United Kingdom