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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

Study Description
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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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer (NSCLC) Drug: ZD1839 (Iressa)

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
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

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Interventions
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Intervention Details:
  • 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
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683306


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Yuri Rukazenkov AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00683306    
Other Study ID Numbers: D791AC00008
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action