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.

First Received: October 12, 2005 Last Updated: April 22, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00238797

Purpose

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

Condition	Intervention	Phase
Glioblastoma	Drug: Gefitinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: ZD1839

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.

Estimated Enrollment:	36
Study Start Date:	February 2003
Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238797

Locations

Sweden
Research Site
Linköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Umeå, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D7913L00088, 1839IL/0088
Study First Received:	October 12, 2005
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00238797 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Glioblastoma multiforme
Brain tumour

Study placed in the following topic categories:

Neuroectodermal Tumors
Brain Neoplasms
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Glioblastoma Multiforme
Glioma
Gefitinib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Glioblastoma
Neoplasms
Neoplasms by Histologic Type
Astrocytoma

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009