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Open-Label Extension of Other SZ1839 (Iressa) Trials

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ClinicalTrials.gov Identifier: NCT00635973
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : April 22, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Drug: Gefitinib (Iressa) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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.
Study Start Date : February 2000
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

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


Intervention Details:
    Drug: Gefitinib (Iressa)
    Iressa


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

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Every 28 days ]
  2. Survival [ Time Frame: Every 28 days ]


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

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00635973     History of Changes
Other Study ID Numbers: 1839IL/0026
D7913C00026
First Posted: March 14, 2008    Key Record Dates
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