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

This study has been completed.
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd. Identifier:
First received: September 21, 2010
Last updated: August 27, 2015
Last verified: July 2015
The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).

Condition Intervention Phase
Lung Cancer
Drug: Amrubicin hydrocloride
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sumitomo Dainippon Pharma Co., Ltd.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 3.3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • response rate (RECIST) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 202
Study Start Date: October 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01207011

32 Sites
Sites, Japan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
  More Information

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd. Identifier: NCT01207011     History of Changes
Other Study ID Numbers: D0702035 
Study First Received: September 21, 2010
Last Updated: August 27, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents processed this record on May 26, 2016