A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
- Signed informed consent
- histologically-or cytologically-confirmed glioblastoma multiforme
- age 18 years or older
- Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for
- co-existing malignancies or malignancies diagnosed within the last 5 years with the
exception of basal cell carcinoma or cervical cancer in situ
- known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumour response at 6 months after the end of combination treatment by computerized tomography scan or magnetic resonance imaging of the brain according to Macdonald criteria.
AstraZeneca Medical Science Director, MD
Sweden: Medical Products Agency
- Glioblastoma multiforme
- Brain tumour