NCT00660504

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

Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Amrubicin Hydrochloride	Amrubicin Hydrochloride combined with cisplatin
DRUG	Etoposide-Cisplatin combined chemotherapy	combined chemotherapy

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-02-01
• Completion: 2012-08-01
• First posted: 2008-04-17
• Last updated: 2014-07-18
• Results posted: 2014-07-04

Locations

15 sites across 1 country: China