Open-Label Extension of Other SZ1839 (Iressa) Trials

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00635973

First received: March 7, 2008

Last updated: April 21, 2009

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 7, 2008
Last Updated Date	April 21, 2009
Start Date ^ICMJE	February 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: March 13, 2008)	Adverse Events [ Time Frame: Every 28 days ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00635973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 13, 2008)	Progression Free Survival [ Time Frame: Every 28 days ] Survival [ Time Frame: Every 28 days ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Open-Label Extension of Other SZ1839 (Iressa) Trials
Official Title ^ICMJE	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.
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: Gefitinib (Iressa) Iressa
Study Arm (s)	Not Provided
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
Estimated Enrollment ^ICMJE	100
Completion Date	October 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00635973
Other Study ID Numbers ^ICMJE	1839IL/0026, D7913C00026
Has Data Monitoring Committee	No
Responsible Party	Alison Armour Medical Science Director, AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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