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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00683306
Expanded Access Status : Approved for marketing
First Posted : May 23, 2008
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date May 21, 2008
First Posted Date May 23, 2008
Last Update Posted Date September 13, 2018
 
Descriptive Information
Brief Title Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Official Title 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 Expanded Access
Expanded Access Type Individual Patients
Condition Non Small Cell Lung Cancer (NSCLC)
Intervention 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
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
Expanded Access Status Approved for marketing
Eligibility Criteria

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, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries 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 NCT00683306
Other Study ID Numbers D791AC00008
Current Responsible Party AstraZeneca
Original Responsible Party Alison Armour (Medical Science Director), AstraZeneca Pharmaceuticals
Current Study Sponsor AstraZeneca
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Yuri Rukazenkov AstraZeneca
PRS Account AstraZeneca
Verification Date August 2018