A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of the CYP1A2 Inhibitor, Fluvoxamine, on Dovitinib (TKI258) Pharmacokinetics in Patients With Advanced Solid Tumors
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
TKI258 pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug)
multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CTKI258A2120
NCT01700270
May 2013
April 2014
Name | Location |
---|---|
Montefiore Medical Center Montefiore Medical Center (SC) | Bronx, New York 10467 |
Cancer Therapy & Research Center / UT Health Science Center SC | San Antonio, Texas 78229 |
Washington University School Of Medicine-Siteman Cancer Ctr Wash Univ | St. Louis, Missouri 63110 |