Status:

COMPLETED

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

Lead Sponsor:

Sumitomo Pharma Co., Ltd.

Conditions:

Lung Cancer

Eligibility:

All Genders

20-74 years

Phase:

PHASE3

Brief 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).

Eligibility Criteria

Inclusion

  • Histological or cytological diagnosis of non-small cell lung cancer (NSCLC)
  • 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy
  • 20 or older but younger than 75 years of age

Exclusion

  • Symptomatic brain metastasis
  • Interstitial pneumonia or pulmonary fibrosis
  • Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
  • Active infection

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

202 Patients enrolled

Trial Details

Trial ID

NCT01207011

Start Date

October 1 2010

End Date

June 1 2014

Last Update

April 12 2022

Active Locations (1)

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32 Sites

Multiple Locations, Japan