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Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00234442
Recruitment Status : Terminated (Closed due to insufficient recruitment.)
First Posted : October 7, 2005
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 5, 2005
First Posted Date  ICMJE October 7, 2005
Last Update Posted Date June 30, 2009
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
Disease control rate (complete response, partial response and stable disease)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00234442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
  • Duration of response
  • Time to progression
  • Overall Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer
Official Title  ICMJE A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy
Brief Summary The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Neoplasms
  • Non Small Cell Lung Cancer
Intervention  ICMJE Drug: Iressa (Gefitinib)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: October 5, 2005)
47
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
  • No symptoms due to brain metastases
  • No previous radiotherapy treatment for the Brain metastases

Exclusion Criteria:

  • No prior chemotherapy
  • No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00234442
Other Study ID Numbers  ICMJE 1839IL/0569
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lucio Crino, MD Bologna, Italy
PRS Account AstraZeneca
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP