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Open-Label Extension of Other SZ1839 (Iressa) Trials

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00635973
First received: March 7, 2008
Last updated: April 21, 2009
Last verified: April 2009
History of Changes
  Purpose

A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.


Condition Intervention Phase
Cancer
 Drug: Gefitinib (Iressa)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Centre, Open-Label Extension Trial of Treatment With ZD1839 (Iressa) in Patients Who Have Been Treated in Other ZD1839 Clinical Trials and May Benefit From Continued Monotherapy ZD 1839.

Resource links provided by NLM:

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Every 28 days ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Every 28 days ]
  • Survival [ Time Frame: Every 28 days ]

Estimated Enrollment: 100
Study Start Date: February 2000
Study Completion Date: October 2003
Intervention Details:
    Drug: Gefitinib (Iressa)
    Iressa
  Eligibility

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

Inclusion Criteria:

  • Received treatment in a previous Iressa clinical trial
  • Provided Informed Consent to participate in the trial
  • 30 days or less since completing the previous Iressa trial.

Exclusion Criteria:

  • Radiotherapy completed more than 14 days before starting treatment in this trial
  • Incomplete healing from prior surgery
  • Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00635973     History of Changes
Other Study ID Numbers: 1839IL/0026, D7913C00026
Study First Received: March 7, 2008
Last Updated: April 21, 2009
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
South Africa: Department of Health

Keywords provided by AstraZeneca:
Iressa
Gefitinib
Cancer
Patients diagnosed with cancer who have previously received Iressa in an Iressa clinical trial

Additional relevant MeSH terms:
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013