The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standard administered chemotherapy) and will measure custirsen blood levels in this cancer population. Finally, the study will evaluate the safety and tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
36
Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle
Teva Investigational Site 002
Detroit, Michigan, United States
Teva Investigational Site 001
Dallas, Texas, United States
Teva Investigational Site 003
San Antonio, Texas, United States
Teva Investigational Site 004
Tacoma, Washington, United States
To evaluate the impact of custirsen on paclitaxel pharmacokinetics
The maximum peak concentration of paclitaxel after administration.
Time frame: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy
Time frame: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
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