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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238797
First Posted: October 14, 2005
Last Update Posted: January 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00238797     History of Changes
Other Study ID Numbers: 1839IL/0088
D7913L00088 ( Other Identifier: AZ )
First Submitted: October 12, 2005
First Posted: October 14, 2005
Last Update Posted: January 21, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Glioblastoma multiforme
Brain tumour

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action