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

September 12, 2018 updated by: AstraZeneca

Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • La Plata, Argentina, 1900
        • Research Site
  • Australia
      • Concord, Australia, 2139
        • Research Site
  • Austria
      • Graz, Austria, AT-8306
        • Research Site
      • Linz, Austria, 4020
        • Research Site
      • Wien, Austria, 1140
        • Research Site
  • Brazil
      • Fortaleza, Brazil, :60431-970
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Rio de Janeiro, Brazil, 20230-130
        • Research Site
      • Sao Paulo, Brazil, 01221-020
        • Research Site
      • Sao Paulo, Brazil, 01420-000
        • Research Site
      • Sorocaba, Brazil, 18030-200
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Sofia, Bulgaria, 1527
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1756
        • Research Site
      • Varna, Bulgaria, 9000
        • Research Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Research Site
  • Estonia
      • Tallinn, Estonia, 11619
        • Research Site
      • Tartu, Estonia, 51003
        • Research Site
  • Hungary
      • Budapest, Hungary, 1529
        • Research Site
      • Deszk, Hungary, 6772
        • Research Site
      • Mosdós, Hungary, 7257
        • Research Site
      • Pécs, Hungary, 7635
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • India
      • Hyderabad, India, 500082
        • Research Site
      • Karnataka, India
        • Research Site
      • Kolkata, India, 700054
        • Research Site
      • Mumbai, India, 400012
        • Research Site
      • New Delhi, India, 110 085
        • Research Site
      • Pune, India, 411001
        • Research Site
      • Vellore, India, 632004
        • Research Site
  • Latvia
      • Daugavpils, Latvia, LV-5420
        • Research Site
      • Riga, Latvia, LV-1002
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50590
        • Research Site
      • Nilai, Malaysia
        • Research Site
      • Penang, Malaysia, 10990
        • Research Site
      • Penang, Malaysia, 11200
        • Research Site
      • Penang, Malaysia
        • Research Site
  • Mexico
      • Durango, Mexico, 34037
        • Research Site
      • Mexico Distrito Federal, Mexico, 06720
        • Research Site
      • Monterrey, Mexico, 64320
        • Research Site
      • Torreon, Mexico, 27000
        • Research Site
  • Philippines
      • Manila, Philippines, 1000
        • Research Site
      • Pasig, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
      • Quezon City, Philippines, 1104
        • Research Site
  • Romania
      • Bucharest, Romania, 022322
        • Research Site
      • Iasi, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Research Site
      • Moscow, Russian Federation, 121356
        • Research Site
  • Singapore
      • Singapore, Singapore, 169610
        • Research Site
  • South Africa
      • Johannesburg, South Africa, 2193
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taipei, Taiwan, 11490
        • Research Site
      • Tao-Yuan, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Istanbul, Turkey, 34030
        • Research Site
      • İstanbul, Turkey
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D791AC00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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