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LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy

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.
ClinicalTrials.gov Identifier: NCT00328588
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : January 2, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.

Condition or disease Intervention/treatment Phase
Lung Cancer Cancer of Lung Cancer of the Lung Non-Small Cell Lung Carcinoma Carcinoma, Non-Small Cell Lung Drug: YM155 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2006
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
7 days continuous infusion
Drug: YM155
IV


Outcome Measures

Primary Outcome Measures :
  1. Tumor response rate (CR+PR) [ Time Frame: In first 6 cycles ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer.
  • Prior chemotherapy regimen(s) for lung cancer

Exclusion Criteria:

  • History of other malignancy in the last 5 years
  • Major surgery within the past 21 days
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): NCT00328588


Locations
Czech Republic
Chomutov, Czech Republic, 43012
Novi Jicin, Czech Republic, 74101
Ostrava, Czech Republic, 70852
Praha, Czech Republic, 15006
Praha, Czech Republic, 18081
Germany
Grosshansdorf, Germany, 22927
Netherlands
Amsterdam, Netherlands, 1081HV
Amsterdam, Netherlands, 3075 EA
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Europe B.V.
More Information

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00328588     History of Changes
Other Study ID Numbers: 155-CL-006
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: January 2, 2008
Last Verified: December 2007

Keywords provided by Astellas Pharma Inc:
Treatment Efficacy
Treatment Effectiveness
Disease Management
Treatment
Safety

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms