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NCT00328588 Clinical Trial

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

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00328588
Other study ID # 155-CL-006
Secondary ID
Status Completed
Phase Phase 2
First received May 19, 2006
Last updated December 26, 2007
Start date December 2006
Est. completion date March 2007

Study information
Verified date December 2007
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: Medicines Evaluation Board (MEB)Czech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• YM155
IV

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Czech Republic,  Germany,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor response rate (CR+PR) In first 6 cycles No
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