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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00298688
First received: March 1, 2006
Last updated: June 11, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
 Drug: Gefitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer

Resource links provided by NLM:

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

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 56
Study Start Date: September 2004
Study Completion Date: March 2007
  Eligibility

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

No publications provided

ClinicalTrials.gov Identifier: NCT00298688     History of Changes
Other Study ID Numbers: 1839IL/0559
Study First Received: March 1, 2006
Last Updated: June 11, 2008
Health Authority: Denmark: Danish Medicines Agency

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
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013