Non Small Cell Lung Cancer (NSCLC)NCT00683306
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
A study testing ZD1839 (Iressa) in people with Non Small Cell Lung Cancer (NSCLC), run by AstraZeneca at 65 sites in 19 countries.
Trial summary
The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- ZD1839 (Iressa)
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 65 sitesin 19 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
- No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.
Who cannot join
- Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
- In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Withdrawal, at any time, from the preceding gefitinib study.
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
Trial locations and contacts
65 sites in 19 countries.
65 sites in 19 countries
Taiwan8 sites
Research Site
Kaohsiung City, 807
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Taipei, 100
Research Site
Taipei, 112
Research Site
Taipei, 11490
Research Site
Taipei
Research Site
Taoyuan, 333
India7 sites
Research Site
Hyderabad, 500082
Research Site
Karnataka
Research Site
Kolkata, 700054
Research Site
Mumbai, 400012
Research Site
New Delhi, 110 085
Research Site
Pune, 411001
Research Site
Vellore, 632004
Brazil6 sites
Research Site
Fortaleza, :60431-970
Research Site
Porto Alegre, 90610-000
Research Site
Rio de Janeiro, 20230-130
Research Site
São Paulo, 01221-020
Research Site
São Paulo, 01420-000
Research Site
Sorocaba, 18030-200
Bulgaria6 sites
Research Site
Plovdiv, 4000
Research Site
Sofia, 1233
Research Site
Sofia, 1527
Research Site
Sofia, 1756
Research Site
Varna, 9000
Research Site
Veliko Tarnovo, 5000
Hungary5 sites
Research Site
Budapest, 1529
Research Site
Deszk, 6772
Research Site
Mosdós, 7257
Research Site
Pécs, 7635
Research Site
Zalaegerszeg, 8900
Malaysia5 sites
Research Site
George Town, 10990
Research Site
George Town, 11200
Research Site
George Town
Research Site
Kampung Baharu Nilai
Research Site
Kuala Lumpur, 50590
Mexico4 sites
Research Site
Durango, 34037
Research Site
Mexico City, 06720
Research Site
Monterrey, 64320
Research Site
Torreón, 27000
Philippines4 sites
Research Site
Manila, 1000
Research Site
Pasig
Research Site
Quezon City, 1104
Research Site
Quezon City
Austria3 sites
Research Site
Graz, AT-8306
Research Site
Linz, 4020
Research Site
Vienna, 1140
Turkey (Türkiye)3 sites
Research Site
Ankara
Research Site
Istanbul, 34030
Research Site
Istanbul
About this study
Official title: Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- ZD1839 (Iressa)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD1839 (Iressa)Drug
Also called Iressa
Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
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 Cancer (NSCLC)Studies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuri Rukazenkov, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683306
- Sponsor's protocol ID
- D791AC00008
- Status last verified
- Aug 2018
- First submitted
- 21 May 2008
- Last updated
- 13 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
- ClinicalTrials.gov ID
- NCT00683306
- Acronym / sponsor ID
- D791AC00008
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- First posted
- 23 May 2008 (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 provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.
Study design
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
- No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.
Key exclusion criteria (4 listed)
- Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
- In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Withdrawal, at any time, from the preceding gefitinib study.
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
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 |
|---|---|---|
| ZD1839 (Iressa)Also: IressaGefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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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.
Yuri Rukazenkov study director
AstraZeneca
65 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZD1839 (Iressa) in people with Non Small Cell Lung Cancer (NSCLC), run by AstraZeneca at 65 sites in 19 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Taiwan, India, Brazil, Bulgaria, Hungary and 14 more countries. 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?
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.
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 13 Sep 2018.