drugset / Trial / NCT00660504
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |