A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
Phase 2
Completed
- Conditions
- Glioblastoma
- Registration Number
- NCT00238797
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Signed informed consent
- histologically-or cytologically-confirmed glioblastoma multiforme
- age 18 years or older
Exclusion Criteria
- Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Disease control rate at 6 months after the combination treatment, clinical or radiological progression-free-survival, overall survival and safety of ZD1839 in combination with radiotherapy.
Trial Locations
- Locations (1)
Research Site
🇸🇪Umeå, Sweden