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
Phase 1
Completed
36 enrolled
Achieve Life Sciences
Teva Branded Pharmaceutical Products R&D, Inc. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Subject | custirsen | Antisense oligonucleotide | 640 mg | Intravenous |