drugset / Trial / NCT01207011

Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

NCT01207011 ↗

Phase 3 Completed 202 enrolled Sumitomo Pharma Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).

Timeline

Start
2010-10
Primary completion
2014-06
Completion
2014-06

Outcome

Missed primary endpoint

paper Amrubicin did not significantly improve the primary endpoint of PFS compared with docetaxel. PMID 28426104 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amrubicin Small molecule 35 mg/m2 Intravenous
Comparator Docetaxel Small molecule 60 mg/m2 Intravenous

Indications