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NCT00298688 Clinical Trial

A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:
Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00298688
Other study ID # 1839IL/0559
Secondary ID
Status Completed
Phase Phase 2
First received March 1, 2006
Last updated June 11, 2008
Start date September 2004
Est. completion date March 2007

Study information
Verified date June 2008
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Gefitinib

Locations
Country Name City State
Denmark Research Site Copenhagen
Denmark Research Site Herlev
United Kingdom Research Site Manchester

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the disease control rate in these patients
Secondary To determine the objective response rate at trail closure in these patients
Secondary To determine the time to progression-or-death in these patients
Secondary To determine overall survival in these patients
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