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

• ClinicalTrials.gov Identifier: NCT00683306
• Expanded Access Status: Approved for marketing
• First Posted: May 23, 2008
• Last Update Posted: September 13, 2018
• Sponsor: AstraZeneca
• 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

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

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