Non-Small Cell Lung CancerNCT01103089
Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
An observational study of Non-Small Cell Lung Cancer, run by AstraZeneca at 11 sites in Netherlands.
Trial summary
The purpose of the study is to determine patient characteristics from patients that have used Iressa for a period of minimal 3 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 10 participants
- Where
- 11 sitesNetherlands
- Study dates
- Mar 2010to Dec 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the gefitinib Expanded Access Programme in the Netherlands.
Who may be able to join
- Participation in the gefitinib Expanded Access Program
- Patient still uses gefitinib in September 2009
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites
Research Site
Amsterdam
Research Site
Apeldoorn
Research Site
Groningen
Research Site
Helmond
Research Site
Hengelo
Research Site
Hoofddorp
Research Site
Leiden
Research Site
The Hague
Research Site
Veldhoven
Research Site
Venlo
Research Site
Zutphen
About this study
The purpose of the study is to determine patient characteristics from patients that have used Iressa for a period of minimal 3 years.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR, gefitinib, observational
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.
Measured: Characteristics will be recorded once, retrospectively
Secondary outcomes (3)
To assess the long-term safety in subjects treated with gefitinib by collecting information on: All adverse events that have lead to an interruption/reduction of gefitinib or another intervention
Measured: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
long-term safety in subjects; what real life data measures are being taken by lung physicians to counter side effects caused by long term gefitinib treatment; the number, reason, effect and description of interventions that have been taken
Measured: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
long-term safety: Number, reason and effect of interruptions during gefitinib use to determine side effects typical for the long-term treatment with gefitinib
Measured: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103089
- Sponsor's protocol ID
- NIS-ONL-IRE-2009/1
- Status last verified
- Oct 2011
- First submitted
- 5 Apr 2010
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
- ClinicalTrials.gov ID
- NCT01103089
- Acronym / sponsor ID
- NIS-ONL-IRE-2009/1
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR, gefitinib, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Apr 2010 (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 patient characteristics from patients that have used Iressa for a period of minimal 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the gefitinib Expanded Access Programme in the Netherlands.
Key inclusion criteria (2 listed)
- Participation in the gefitinib Expanded Access Program
- Patient still uses gefitinib in September 2009
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.
Time frame: Characteristics will be recorded once, retrospectively
3 secondary outcomes
To assess the long-term safety in subjects treated with gefitinib by collecting information on: All adverse events that have lead to an interruption/reduction of gefitinib or another intervention
Time frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
long-term safety in subjects; what real life data measures are being taken by lung physicians to counter side effects caused by long term gefitinib treatment; the number, reason, effect and description of interventions that have been taken
Time frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
long-term safety: Number, reason and effect of interruptions during gefitinib use to determine side effects typical for the long-term treatment with gefitinib
Time frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
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 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by AstraZeneca at 11 sites in Netherlands.
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 2 inclusion and 0 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 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. 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.
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?
The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC. (time frame: Characteristics will be recorded once, retrospectively). 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 Oct 2011.