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Iressa Follow-up Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00357734
First received: July 26, 2006
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).


Condition Intervention Phase
Lung Cancer
Breast Cancer
 Drug: Gefitinib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials

Resource links provided by NLM:

Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839. [ Time Frame: Until 30 days after the last dose of trial drug ] [ Designated as safety issue: No ]
    Any AEs and SAEs occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease


Secondary Outcome Measures:
  • To estimate clinical benefit of ZD1839 therapy by assessing progression free survival and overall survival. [ Time Frame: Every 3 months until death of last patient ] [ Designated as safety issue: No ]
    Patients are followed for progression and overall survival


Estimated Enrollment: 100
Study Start Date: January 2005
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib (ZD1839)
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
 Drug: Gefitinib
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent to participate in the trial.
  • Female or male aged 18 years and over.
  • Patients with previously diagnosed cancer who have been treated with ZD1839 in a parent ZD1839 clinical trial and may benefit from continuation

Exclusion Criteria:

  • Known severe hypersensitivity to ZD1839
  • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
  • Withdrawal from a parent ZD1839 trial because of tumor progress
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357734

Locations
Germany
Research Site
Berlin, Germany
Research Site
Freiburg, Germany
Research Site
Gauting, Germany
Research Site
Grosshansdorf, Germany
Research Site
Heidelberg, Germany
Research Site
Hemer, Germany
Research Site
Jena, Germany
Research Site
Minden, Germany
Research Site
Tuebingen, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Germany Medical Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00357734     History of Changes
Other Study ID Numbers: 1839IL/0555, D7913L00008
Study First Received: July 26, 2006
Last Updated: April 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
lung cancer
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic 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