CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Amrubicin Hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00660504
NCT00660504Phase 3Completed

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

Sumitomo Pharma (Suzhou) Co., Ltd.·interventional·Posted Apr 17, 2008·Updated Jul 18, 2014

In Brief

A Phase 3 clinical trial evaluating Amrubicin Hydrochloride and Etoposide-Cisplatin combined chemotherapy for Lung Cancer. Completed, enrolled 300 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.2 years ago

Interventions

Amrubicin Hydrochloridedrug

Amrubicin Hydrochloride combined with cisplatin

Etoposide-Cisplatin combined chemotherapydrug

combined chemotherapy