drugset / Trial / NCT00660504

Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

NCT00660504

Phase 3 Completed 300 enrolled Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Timeline

Start
2008-04
Primary completion
2012-02
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Amrubicin Small molecule 40 mg/m2
Subject Cisplatin Other / unclassified 60 mg/m2
Subject Cisplatin Other / unclassified 80 mg/m2
Comparator Etoposide Small molecule 100 mg/m2

Indications