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Open-Label Extension of Other SZ1839 (Iressa) Trials

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635973
First Posted: March 14, 2008
Last Update Posted: April 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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: 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)
    Iressa
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00635973     History of Changes
Other Study ID Numbers: 1839IL/0026
D7913C00026
First Submitted: March 7, 2008
First Posted: March 14, 2008
Last Update Posted: April 22, 2009
Last Verified: April 2009

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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action