AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
189
Yale Cancer Center
New Haven, Connecticut, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Maximum-tolerated dose and dose-limiting toxicity of AEE788
Time frame: 4.5 years
Maximum-tolerated dose, safety and tolerability of AEE788
Time frame: 4.5 years
Single dose and repeated dose pharmacokinetic profile of AEE788
Time frame: 4.5 years
Pharmacodynamic effects
Time frame: 4.5 years
Changes in glucose metabolism/cell viability
Time frame: 4.5 years
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Institute of Drug Development/Cancer Therapy and Research Center
San Antonio, Texas, United States