Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

Tracking Information
First Submitted Date ICMJE	May 21, 2008
First Posted Date ICMJE	May 23, 2008
Last Update Posted Date	December 18, 2017
Actual Study Start Date ICMJE	January 17, 2005
Actual Primary Completion Date	October 2, 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 22, 2008)	There are no outcome variables in this programme. No formal analysis or statistical analysis will be performed on any data obtained. Serious adverse event data will be collected for regulatory reporting purposes only. [ Time Frame: Study medication will continue until the patient shows disease progression, disease related symptomatic progression, withdraws consent or experiences toxicity leading to withdrawal ofstudy treatment. ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00683306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Official Title ICMJE	Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
Brief 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 derive benefit.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Non Small Cell Lung Cancer (NSCLC)
Intervention ICMJE	Drug: ZD1839 (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.; Other Name: Iressa
Study Arms	Experimental: 1; ZD 1839 (Iressa); Intervention: Drug: ZD1839 (Iressa)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 24, 2017)	94
Original Estimated Enrollment ICMJE; (submitted: May 22, 2008)	533
Actual Study Completion Date	October 2, 2017
Actual Primary Completion Date	October 2, 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 130 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Argentina, Australia, Austria, Brazil, Bulgaria, Estonia, Hungary, India, Latvia, Malaysia, Mexico, Philippines, Romania, Russian Federation, Singapore, South Africa, Taiwan, Thailand, Turkey
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00683306
Other Study ID Numbers ICMJE	D791AC00008
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	AstraZeneca
Study Sponsor ICMJE	AstraZeneca
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Haiyi Jiang AstraZeneca
PRS Account	AstraZeneca
Verification Date	December 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP