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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT01207011
First received: September 21, 2010
Last updated: March 12, 2013
Last verified: February 2012
History of Changes
  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
Masking: Open Label
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:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Dainippon Sumitomo Pharma:

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

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • response rate (RECIST) [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • clinical benefit [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • safety [ Time Frame: Until death ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: October 2010
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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207011

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

No publications provided

Responsible Party: Dainippon Sumitomo Pharma Co., Ltd
ClinicalTrials.gov Identifier: NCT01207011     History of Changes
Other Study ID Numbers: D0702035
Study First Received: September 21, 2010
Last Updated: March 12, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Amrubicin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013