NCT00238797

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2003

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

First QC Date

October 12, 2005

Last Update Submit

January 20, 2011

Conditions

Glioblastoma

Keywords

Glioblastoma multiformeBrain tumour

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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.

Interventions

GefitinibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • histologically-or cytologically-confirmed glioblastoma multiforme
  • age 18 years or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Linköping, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Umeå, Sweden

Location

MeSH Terms

Conditions

GlioblastomaBrain Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

February 1, 2003

Study Completion

March 1, 2006

Last Updated

January 21, 2011

Record last verified: 2011-01

Locations

SE(3)