Small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer
Verified date | June 2008 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Research Site | Copenhagen | |
Denmark | Research Site | Herlev | |
United Kingdom | Research Site | Manchester |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Denmark, United Kingdom,
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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