Small Cell Lung CancerPhase 2NCT00298688
A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer
A Phase 2 study testing Gefitinib in people with Small Cell Lung Cancer, run by AstraZeneca at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Gefitinib
- How many people
- 56 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2004to Mar 2007
- 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
- Provision of written informed consent
- Histologically confirmed, relapsed or refractory SCLCr
- Aged 18 or over and a life expectancy of more than 2 months
Who cannot join
- Any evidence of clinically active interstitial lung disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer
The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib
- Conditions
- Small Cell Lung Cancer
- Being tested
- Gefitinib
- Medical subject headings
- Small Cell Lung Carcinoma
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.
To determine the disease control rate in these patients
Secondary outcomes (3)
To determine the objective response rate at trail closure in these patients
To determine the time to progression-or-death in these patients
To determine overall survival in these patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startSep 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies 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
- 56 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Iressa Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298688
- Sponsor's protocol ID
- 1839IL/0559
- Status last verified
- Jun 2008
- First submitted
- 1 Mar 2006
- Last updated
- 12 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00298688
- Acronym / sponsor ID
- 1839IL/0559
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Mar 2007 (actual)
- First posted
- 3 Mar 2006 (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 this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib
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)
- Provision of written informed consent
- Histologically confirmed, relapsed or refractory SCLCr
- Aged 18 or over and a life expectancy of more than 2 months
Key exclusion criteria (2 listed)
- Any evidence of clinically active interstitial lung disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.
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
To determine the disease control rate in these patients
3 secondary outcomes
To determine the objective response rate at trail closure in these patients
To determine the time to progression-or-death in these patients
To determine overall survival in these patients
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 12 Jun 2008.
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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 Iressa Medical Science Director, MD study director
AstraZeneca
3 sites in 2 countries: 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 Small Cell Lung Cancer, run by AstraZeneca at 3 sites in 2 countries.
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 2 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 12 Jun 2008. 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 Denmark, United Kingdom. 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?
To determine the disease control rate in these patients. 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 12 Jun 2008.