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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00242801
First Posted: October 21, 2005
Last Update Posted: April 23, 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
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 Intervention Phase
NSCLC Drug: Gefitinib Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
  • · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
  • · objective tumour response (CR + PR)
  • · ZD1839 + BSC versus Placebo + BSC in terms of tolerability
  • · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes

Estimated Enrollment: 1692
Study Start Date: July 2003
Study Completion Date: April 2005
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00242801


  Show 213 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Oncology Medical Science Direction AstraZeneca
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00242801     History of Changes
Other Study ID Numbers: 1839IL/0709
ISEL
First Submitted: October 19, 2005
First Posted: October 21, 2005
Last Update Posted: April 23, 2009
Last Verified: April 2009

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