- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635973
Open-Label Extension of Other SZ1839 (Iressa) Trials
April 21, 2009 updated by: AstraZeneca
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: Every 28 days
|
Every 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: Every 28 days
|
Every 28 days
|
Survival
Time Frame: Every 28 days
|
Every 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2000
Study Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
March 7, 2008
First Submitted That Met QC Criteria
March 13, 2008
First Posted (Estimate)
March 14, 2008
Study Record Updates
Last Update Posted (Estimate)
April 22, 2009
Last Update Submitted That Met QC Criteria
April 21, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1839IL/0026
- D7913C00026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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