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A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00298688
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : June 12, 2008
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Gefitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer
Study Start Date : September 2004
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources




Primary Outcome Measures :
  1. To determine the disease control rate in these patients

Secondary Outcome Measures :
  1. To determine the objective response rate at trail closure in these patients
  2. To determine the time to progression-or-death in these patients
  3. To determine overall survival in these patients


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:

  • Provision of written informed consent
  • Histologically confirmed, relapsed or refractory SCLCr
  • Aged 18 or over and a life expectancy of more than 2 months

Exclusion Criteria:

  • Any evidence of clinically active interstitial lung disease
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.

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): NCT00298688


Locations
Denmark
Research Site
Copenhagen, Denmark
Research Site
Herlev, Denmark
United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca

Additional Information:
ClinicalTrials.gov Identifier: NCT00298688     History of Changes
Other Study ID Numbers: 1839IL/0559
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008

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