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

NCT00660504 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-07-18

Study results available
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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

Interventions

DRUG

Amrubicin Hydrochloride

Amrubicin Hydrochloride combined with cisplatin

DRUG

Etoposide-Cisplatin combined chemotherapy

combined chemotherapy

Sponsors & Collaborators

  • Sumitomo Pharma (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan Sun, MD · Cancer Hospital Chinese Academy of Medical Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-02-29
Completion
2012-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00660504 on ClinicalTrials.gov