A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms, Non Small Cell Lung Cancer
Both
Brain Neoplasms, Non Small Cell Lung Cancer
Trial Information
A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy
Inclusion Criteria:
- Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
- No symptoms due to brain metastases
- No previous radiotherapy treatment for the Brain metastases
Exclusion Criteria:
- No prior chemotherapy
- No other co-existing malignancies or malignancies diagnosed within the last 5 years
with the exception of basal cell carcinoma or cervical cancer in situ
- Any evidence of severe or uncontrolled systemic disease (e.g., unstable or
uncompensated respiratory, cardiac, hepatic, or renal disease)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease control rate (complete response, partial response and stable disease)
Principal Investigator
Lucio Crino, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Bologna, Italy
Authority:
Italy: Ministry of Health
Study ID:
1839IL/0569
NCT ID:
NCT00234442
Start Date:
July 2004
Completion Date:
February 2006
Related Keywords:
- Brain Neoplasms
- Non Small Cell Lung Cancer
- Non symptomatic brain metastases
- Iressa
- Brain Neoplasms
- Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
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