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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:
AstraZeneca Identifier:
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.

Condition Intervention Phase
Drug: Gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00238797

Research Site
Linköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Umeå, Sweden
Sponsors and Collaborators
Study Director: AstraZeneca Medical Science Director, MD AstraZeneca
  More Information Identifier: NCT00238797     History of Changes
Other Study ID Numbers: 1839IL/0088
D7913L00088 ( Other Identifier: AZ )
Study First Received: October 12, 2005
Last Updated: January 20, 2011

Keywords provided by AstraZeneca:
Glioblastoma multiforme
Brain tumour

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017