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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00328588
First received: May 19, 2006
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Tumor response rate (CR+PR) [ Time Frame: In first 6 cycles ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: December 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
7 days continuous infusion
 Drug: YM155
IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 BV
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00328588     History of Changes
Other Study ID Numbers: 155-CL-006
Study First Received: May 19, 2006
Last Updated: December 26, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Medicines Evaluation Board (MEB)
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 16, 2013