drugset / Trial / NCT01497470

A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment Regimen

NCT01497470

NaSingle-groupOpen-label

Summary

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.

Timeline

Start
2012-04
Primary completion
2013-07
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous
Subject custirsen Antisense oligonucleotide 640 mg Intravenous

Indications