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
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Glioblastoma
Both
Glioblastoma
Trial Information
A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
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.
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:
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.
Principal Investigator
AstraZeneca Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Sweden: Medical Products Agency
Study ID:
1839IL/0088
NCT ID:
NCT00238797
Start Date:
February 2003
Completion Date:
March 2006
Related Keywords:
- Glioblastoma
- Glioblastoma multiforme
- Brain tumour
- Glioblastoma
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