CancerPhase 3NCT00635973
Open-Label Extension of Other SZ1839 (Iressa) Trials
A Phase 3 study testing Gefitinib (Iressa) in people with Cancer, run by AstraZeneca.
Trial summary
A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Gefitinib (Iressa)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Oct 2003
- Phase
- Phase 3
- 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
- Received treatment in a previous Iressa clinical trial
- Provided Informed Consent to participate in the trial
- 30 days or less since completing the previous Iressa trial.
Who cannot join
- Radiotherapy completed more than 14 days before starting treatment in this trial
- Incomplete healing from prior surgery
- Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs
About this study
Official title: Multi-Centre, Open-Label Extension Trial of Treatment With ZD1839 (Iressa) in Patients Who Have Been Treated in Other ZD1839 Clinical Trials and May Benefit From Continued Monotherapy ZD 1839.
A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.
- Conditions
- Cancer
- Being tested
- Gefitinib (Iressa)
- Keywords
- Iressa, Gefitinib, Cancer, Patients diagnosed with cancer who have previously received Iressa in an Iressa clinical trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefitinib (Iressa)Drug
Iressa
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Every 28 days
Secondary outcomes (2)
Progression Free Survival
Measured: Every 28 days
Survival
Measured: Every 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startFeb 2000
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635973
- Sponsor's protocol ID
- 1839IL/0026
- Other IDs
- D7913C00026
- Status last verified
- Apr 2009
- First submitted
- 7 Mar 2008
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre, Open-Label Extension Trial of Treatment With ZD1839 (Iressa) in Patients Who Have Been Treated in Other ZD1839 Clinical Trials and May Benefit From Continued Monotherapy ZD 1839.
- ClinicalTrials.gov ID
- NCT00635973
- Acronym / sponsor ID
- 1839IL/0026
- Conditions
- Cancer
- Keywords
- Iressa, Gefitinib, Cancer, Patients diagnosed with cancer who have previously received Iressa in an Iressa clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Study completion
- Oct 2003 (actual)
- First posted
- 14 Mar 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.
A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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)
- Received treatment in a previous Iressa clinical trial
- Provided Informed Consent to participate in the trial
- 30 days or less since completing the previous Iressa trial.
Key exclusion criteria (3 listed)
- Radiotherapy completed more than 14 days before starting treatment in this trial
- Incomplete healing from prior surgery
- Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs
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 (Iressa)Iressa | Drug | – |
Primary outcome
Adverse Events
Time frame: Every 28 days
2 secondary outcomes
Progression Free Survival
Time frame: Every 28 days
Survival
Time frame: Every 28 days
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 22 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gefitinib (Iressa) in people with Cancer, run by AstraZeneca.
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: finished, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Adverse Events (time frame: Every 28 days). 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 22 Apr 2009.