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Open-Label Extension of Other SZ1839 (Iressa) Trials

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 7, 2008
Last updated: April 21, 2009
Last verified: April 2009
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: Intervention Model: Single Group Assignment
Masking: None (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:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Alison Armour Medical Science Director, AstraZeneca Identifier: NCT00635973     History of Changes
Other Study ID Numbers: 1839IL/0026
Study First Received: March 7, 2008
Last Updated: April 21, 2009

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

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017