Back to resultsLUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy
Primary Purpose
Lung Cancer, Cancer of Lung, Cancer of the Lung
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM155
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
7 days continuous infusion
Outcomes
Primary Outcome Measures
Tumor response rate (CR+PR)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00328588
Brief Title
LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
Brief Summary
A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Cancer of Lung, Cancer of the Lung, Non-Small Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung
Keywords
Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
7 days continuous infusion
Intervention Type
Drug
Intervention Name(s)
YM155
Intervention Description
IV
Primary Outcome Measure Information:
Title
Tumor response rate (CR+PR)
Time Frame
In first 6 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Chomutov
ZIP/Postal Code
43012
Country
Czech Republic
City
Novi Jicin
ZIP/Postal Code
74101
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
70852
Country
Czech Republic
City
Praha
ZIP/Postal Code
15006
Country
Czech Republic
City
Praha
ZIP/Postal Code
18081
Country
Czech Republic
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy
We'll reach out to this number within 24 hrs