A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme

AstraZeneca1 site in 1 country36 target enrollmentFebruary 2003

ConditionsGlioblastoma

DrugsGefitinib

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Glioblastoma
Sponsor: AstraZeneca
Enrollment: 36
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

March 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 Outcomes

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.