drugset / Trial / NCT01299415

Safety and Pharmacokinetics of ASA404 When Given Together With Fluvoxamine, a Selective Serotonin Receptor Reuptake Inhibitor and CYP1A2 Inhibitor

NCT01299415

Phase 1 Terminated 17 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. The purpose of the Extension Phase is to provide continued treatment for those patients that have not progressed during the Core Phase and to collect safety data on ASA404 when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin chemotherapy regimen.

Timeline

Start
2009-08
Primary completion
2010-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject ASA404 Unknown

Indications