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

April 9, 2022 updated by: Sumitomo Pharma Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan
        • 32 Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 AMR
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.
Active Comparator: 2 DOC
Drug: Docetaxel
DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 3.3 months
3.3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 12 months
12 months
Number of Participants with Adverse Events
Time Frame: 4 months
4 months
response rate (RECIST)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0702035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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