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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207011
First Posted: September 22, 2010
Last Update Posted: August 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ]
  • response rate (RECIST) [ Time Frame: 3 months ]
  • Number of Participants with Adverse Events [ Time Frame: 4 months ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207011


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

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01207011     History of Changes
Other Study ID Numbers: D0702035
First Submitted: September 21, 2010
First Posted: September 22, 2010
Last Update Posted: August 28, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Amrubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action