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NCT01207011 Clinical Trial

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

Lung Cancer Clinical Trial

Official title:
A Randomised, Open-Label Phase 3 Trial Comparing Amrubicin Versus Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01207011
Other study ID # D0702035
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2010
Est. completion date June 2014

Study information
Verified date April 2022
Source Sumitomo Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 202
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility Inclusion Criteria: - 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 Criteria: - Symptomatic brain metastasis - Interstitial pneumonia or pulmonary fibrosis - Abnormal cardiac function or myocardial infraction within 6 months before study enrollment - Active infection

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amrubicin hydrocloride
AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.
• Docetaxel
DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.

Locations
Country Name City State
Japan 32 Sites Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression free survival 3.3 months
Secondary Overall survival 12 months
Secondary response rate (RECIST) 3 months
Secondary Number of Participants with Adverse Events 4 months
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