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NCT00238797 Clinical Trial

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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238797
Other study ID # 1839IL/0088
Secondary ID D7913L00088
Status Completed
Phase Phase 2
First received October 12, 2005
Last updated January 20, 2011
Start date February 2003
Est. completion date March 2006

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gefitinib

Locations
Country Name City State
Sweden Research Site Linköping
Sweden Research Site Stockholm
Sweden Research Site Umeå

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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.
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