The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2)
Chapel Hill, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)
Nashville, Tennessee, United States
Occurrence of dose-limiting toxicities
Time frame: Cycle 1
Frequency and type of adverse events
Time frame: throughout the study
Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability)
Time frame: 3 months
Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters)
Time frame: 4 weeks
Pharmacodynamic measurements to determine how LCL161 interacts with proteins related to cancer such as cIAP, cytokines, and cell death markers; hair, skin and tumor samples will be evaluated for target inhibition
Time frame: Intermittent throughout treatment period
Solid tumor response criteria will be used to identify any anti-tumor activity
Time frame: After a minimum of 2 cycles
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