A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of TKI258 on the Pharmacokinetics of Caffeine, Diclofenac, Omeprazole and Midazolam Administered as a Four-drug Cocktail in Patients With Advanced Solid Tumors, Excluding Breast Cancer
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probe substrate pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug)
multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CTKI258A2119
NCT01596647
May 2012
July 2013
Name | Location |
---|---|
University of Minnesota | Minneapolis, Minnesota 55455 |
Henry Ford Hospital Henry Ford | Detroit, Michigan 48202 |
University of Kansas Cancer Center Medical Center | Kansas City, Kansas 66160 |
Comprehensive Cancer Centers | Las Vegas, Nevada 89169 |
Cancer Institute of New Jersey Dept of Cancer Institute of NJ | New Brunswick, New Jersey 08901 |