Brain NeoplasmsPhase 2NCT00234442
Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer
A Phase 2 study testing Iressa (Gefitinib) in people with Brain Neoplasms and Non Small Cell Lung Cancer, run by AstraZeneca at 4 sites in Italy.
Trial summary
The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Non Small Cell Lung Cancer
- What is being tested?
- Iressa (Gefitinib)
- How many people
- 47 participants
- Where
- 4 sitesItaly
- Study dates
- Jul 2004to Feb 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
- Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
- No symptoms due to brain metastases
- No previous radiotherapy treatment for the Brain metastases
Who cannot join
- No prior chemotherapy
- No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Research Site
Bologna
Research Site
Orbassano
Research Site
Parma
Research Site
Rozzano
About this study
Official title: A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy
The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC
- Conditions
- Brain Neoplasms, Non Small Cell Lung Cancer
- Being tested
- Iressa (Gefitinib)
- Keywords
- Non symptomatic brain metastases, Iressa
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iressa (Gefitinib)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (complete response, partial response and stable disease)
Secondary outcomes (3)
Duration of response
Time to progression
Overall Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startJul 2004
- Study completionFeb 2006
Why it stopped: Closed due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies 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
- 47 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lucio Crino, MD, Principal investigator, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234442
- Sponsor's protocol ID
- 1839IL/0569
- Status last verified
- Jun 2009
- First submitted
- 5 Oct 2005
- Last updated
- 30 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT00234442
- Acronym / sponsor ID
- 1839IL/0569
- Conditions
- Brain Neoplasms, Non Small Cell Lung Cancer
- Keywords
- Non symptomatic brain metastases, Iressa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to insufficient recruitment.
- Enrolment
- 47 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Feb 2006
- First posted
- 7 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 aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC
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)
- Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
- No symptoms due to brain metastases
- No previous radiotherapy treatment for the Brain metastases
Key exclusion criteria (3 listed)
- No prior chemotherapy
- No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
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 |
|---|---|---|
| Iressa (Gefitinib) | Drug | – |
Primary outcome
Disease control rate (complete response, partial response and stable disease)
3 secondary outcomes
Duration of response
Time to progression
Overall Survival
Results and safety
The study was stopped early (reason given: Closed due to insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
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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.
Lucio Crino, MD principal investigator
Bologna, Italy
4 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 Iressa (Gefitinib) in people with Brain Neoplasms and Non Small Cell Lung Cancer, run by AstraZeneca at 4 sites in Italy.
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: stopped early, as of the sponsor's last update on 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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 was stopped early (reason given: Closed due to insufficient recruitment.). Results are not available in the source record.
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?
Disease control rate (complete response, partial response and stable disease). 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 30 Jun 2009.