Back to resultsA Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent Histologically confirmed, relapsed or refractory SCLCr Aged 18 or over and a life expectancy of more than 2 months Exclusion Criteria: Any evidence of clinically active interstitial lung disease Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.
Sites / Locations
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
To determine the disease control rate in these patients
Secondary Outcome Measures
To determine the objective response rate at trail closure in these patients
To determine the time to progression-or-death in these patients
To determine overall survival in these patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00298688
Brief Title
A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer
Official Title
Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Primary Outcome Measure Information:
Title
To determine the disease control rate in these patients
Secondary Outcome Measure Information:
Title
To determine the objective response rate at trail closure in these patients
Title
To determine the time to progression-or-death in these patients
Title
To determine overall survival in these patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent
Histologically confirmed, relapsed or refractory SCLCr
Aged 18 or over and a life expectancy of more than 2 months
Exclusion Criteria:
Any evidence of clinically active interstitial lung disease
Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Iressa Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Copenhagen
Country
Denmark
Facility Name
Research Site
City
Herlev
Country
Denmark
Facility Name
Research Site
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer
We'll reach out to this number within 24 hrs