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

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • 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

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

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

May 21, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Non Small Cell Lung Cancer (NSCLC)

Clinical Trials on ZD1839 (Iressa)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe