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Trial record 23 of 531 for:    Argentina | Bulgaria

Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

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. Identifier: NCT00242801
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : April 23, 2009
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Brief Summary:
This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Gefitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
Study Start Date : July 2003
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Primary Outcome Measures :
  1. The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care

Secondary Outcome Measures :
  1. · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
  2. · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
  3. · objective tumour response (CR + PR)
  4. · ZD1839 + BSC versus Placebo + BSC in terms of tolerability
  5. · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes

Information from the National Library of Medicine

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

Inclusion Criteria:

  • · Life expectancy of at least 8 weeks.

    • Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
    • Not suitable for chemotherapy
    • WHO Performance status 0,1, 2 or 3

Exclusion Criteria:

  • Newly diagnosed CNS mets
  • Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
  • ALT/AST greater than 5 x upper limit of normal
  • ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242801

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Sponsors and Collaborators
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Study Director: AstraZeneca Oncology Medical Science Direction AstraZeneca

Additional Information:
Layout table for additonal information Identifier: NCT00242801     History of Changes
Other Study ID Numbers: 1839IL/0709
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action