A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
This study has been completed.
Information provided by:
First received: October 12, 2005
Last updated: January 20, 2011
Last verified: January 2011
The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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:
- 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.
|Study Start Date:||February 2003|
|Study Completion Date:||March 2006|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238797
Sponsors and Collaborators
|Study Director:||AstraZeneca Medical Science Director, MD||AstraZeneca|