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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00683306
First received: May 21, 2008
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
 Drug: ZD1839 (Iressa)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • There are no outcome variables in this programme. No formal analysis or statistical analysis will be performed on any data obtained. Serious adverse event data will be collected for regulatory reporting purposes only. [ Time Frame: Study medication will continue until the patient shows disease progression, disease related symptomatic progression, withdraws consent or experiences toxicity leading to withdrawal ofstudy treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 533
Study Start Date: January 2005
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683306

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Alison Armour AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00683306     History of Changes
Other Study ID Numbers: D791AC00008
Study First Received: May 21, 2008
Last Updated: April 30, 2013
Health Authority: Austria: Ethikkommission
Bulgaria: Ministry of Health
Hungary: National Institute of Pharmacy
Mexico: Ethics Committee
Romania: Ministry of Public Health
Russia: Ethics Committee
Thailand: Ethical Committee

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013