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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242801
First received: October 19, 2005
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242801

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

No publications provided

ClinicalTrials.gov Identifier: NCT00242801     History of Changes
Other Study ID Numbers: 1839IL/0709, ISEL
Study First Received: October 19, 2005
Last Updated: April 22, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013