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Completed

NCT Number: NCT01207011

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

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

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

32 Sites

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amrubicin hydrocloride

Drug

AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.

docetaxel

Drug

DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.

Primary outcomes

  1. Progression free survival

    Time frame: 3.3 months

Secondary outcomes

  1. Overall survival

    Time frame: 12 months

  2. response rate (RECIST)

    Time frame: 3 months

  3. Number of Participants with Adverse Events

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2010
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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