GlioblastomaPhase 2NCT00238797
A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
A Phase 2 study testing Gefitinib in people with Glioblastoma, run by AstraZeneca at 3 sites in Sweden.
Trial summary
The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Gefitinib
- How many people
- 36 participants
- Where
- 3 sitesSweden
- Study dates
- Feb 2003to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- histologically-or cytologically-confirmed glioblastoma multiforme
- age 18 years or older
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
About this 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
The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.
- Conditions
- Glioblastoma
- Being tested
- Gefitinib
- Keywords
- Glioblastoma multiforme, Brain tumour
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startFeb 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238797
- Sponsor's protocol ID
- 1839IL/0088
- Other IDs
- D7913L00088
- Status last verified
- Jan 2011
- First submitted
- 12 Oct 2005
- Last updated
- 21 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00238797
- Acronym / sponsor ID
- 1839IL/0088
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma multiforme, Brain tumour
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Mar 2006 (actual)
- First posted
- 14 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- histologically-or cytologically-confirmed glioblastoma multiforme
- age 18 years or older
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gefitinib | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Medical Science Director, MD study director
AstraZeneca
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib in people with Glioblastoma, run by AstraZeneca at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2011; AzTrials last refreshed its copy on 27 Oct 2026.