An Open-Label, One-Arm, One-Sequence Crossover Drug-Drug Interaction Study in Advanced Solid Tumor Subjects Subjects to Evaluate the Potential Effect of Custirsen (OGX-011) on the Pharmacokinetics of Paclitaxel
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
To evaluate the impact of custirsen on paclitaxel pharmacokinetics
The maximum peak concentration of paclitaxel after administration.
0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
No
United States: Food and Drug Administration
TV1011-DDI-105
NCT01497470
April 2012
April 2013
Name | Location |
---|---|
Teva Investigational Site 002 | Detroit, Michigan |
Teva Investigational Site 001 | Dallas, Texas |
Teva Investigational Site 003 | San Antonio, Texas |
Teva Investigational Site 004 | Tacoma, Washington |