Non Small Cell Lung CancerNCT00684385
An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck
A study testing ZD1839 in people with Non Small Cell Lung Cancer and Cancer of the Head and Neck, run by AstraZeneca at 34 sites in 4 countries.
Trial summary
The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Cancer of the Head and Neck
- What is being tested?
- ZD1839
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 34 sitesin 4 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
- Have received at least one course of standard systemic chemotherapy or radiation therapy
- Are ineligible for chemotherapy or radiotherapy
- Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H\&NC
- Are, in the investigators opinion, not medically suitable for chemotherapy.
Who cannot join
- Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
- Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
- Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
- Incomplete healing from prior oncologic or other major surgery
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
Germany25 sites
Research Site
Berlin, 10117
Research Site
Berlin, 13125
Research Site
Berlin, 13189
Research Site
Berlin, 14165
Research Site
Essen, 45122
Research Site
Frankfurt, 60590
Research Site
Freiburg im Breisgau, 79106
Research Site
Göttingen, 37075
Research Site
Großhansdorf, 22927
Research Site
Halle, 06112
Research Site
Halle, 06120
Research Site
Heidelberg, 69126
Research Site
Kiel, 24105
Research Site
Laatzen, 30880
Research Site
Lemgo, 32657
Research Site
Löwenstein, 74245
Research Site
Mainz, 55131
Research Site
München, 81675
Research Site
Nuremberg, 90419
Research Site
Oldenburg, 26121
Research Site
Oldenburg, 26133
Research Site
Stralsund, 18437
Research Site
Stuttgart, 70174
Research Site
Trier, 54292
Research Site
Wiesbaden, 65199
Hungary5 sites
Research Site
Budapest, 1121
Research Site
Budapest, 1122
Research Site
Budapest, 1125
Research Site
Kecskemét, 6000
Research Site
Törökbálint, 2045
Poland3 sites
Research Site
Gdansk, 80-952
Research Site
Warsaw, 02-781
Research Site
Zabrze, 41-803
About this study
Official title: An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)
The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
- Being tested
- ZD1839
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD1839Drug
Also called Iressa
250mg administered daily for patients with NSCLC and500mg daily for patients with H\&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H\&NC will take two tablets at each dose administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 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 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
- 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
- NCT00684385
- Sponsor's protocol ID
- 1839IL/0052
- Other IDs
- D7914C00052
- Status last verified
- Feb 2019
- First submitted
- 21 May 2008
- Last updated
- 14 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)
- ClinicalTrials.gov ID
- NCT00684385
- Acronym / sponsor ID
- 1839IL/0052
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- First posted
- 26 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 ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
Study design
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have received at least one course of standard systemic chemotherapy or radiation therapy
- Are ineligible for chemotherapy or radiotherapy
- Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H\&NC
- Are, in the investigators opinion, not medically suitable for chemotherapy.
Key exclusion criteria (4 listed)
- Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
- Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
- Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
- Incomplete healing from prior oncologic or other major surgery
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 |
|---|---|---|
| ZD1839Also: Iressa250mg administered daily for patients with NSCLC and500mg daily for patients with H\&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H\&NC will take two tablets at each dose administration. | 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 14 Mar 2019.
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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
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZD1839 in people with Non Small Cell Lung Cancer and Cancer of the Head and Neck, run by AstraZeneca at 34 sites in 4 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 4 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 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, Hungary, Poland, 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.
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 14 Mar 2019.