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Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01103089
First received: April 5, 2010
Last updated: October 11, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of the study is to determine patient characteristics from patients that have used Iressa for a period of minimal 3 years.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)

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 following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC. [ Time Frame: Characteristics will be recorded once, retrospectively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the long-term safety in subjects treated with gefitinib by collecting information on: All adverse events that have lead to an interruption/reduction of gefitinib or another intervention [ Time Frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years) ] [ Designated as safety issue: Yes ]
  • long-term safety in subjects; what real life data measures are being taken by lung physicians to counter side effects caused by long term gefitinib treatment; the number, reason, effect and description of interventions that have been taken [ Time Frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years) ] [ Designated as safety issue: No ]
  • long-term safety: Number, reason and effect of interruptions during gefitinib use to determine side effects typical for the long-term treatment with gefitinib [ Time Frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years) ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from the gefitinib Expanded Access Programme in the Netherlands.

Criteria

Inclusion Criteria:

  • Participation in the gefitinib Expanded Access Program
  • Patient still uses gefitinib in September 2009
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103089

Locations
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Apeldoorn, Netherlands
Research Site
Den Haag, Netherlands
Research Site
Groningen, Netherlands
Research Site
Helmond, Netherlands
Research Site
Hengelo, Netherlands
Research Site
Hoofddorp, Netherlands
Research Site
Leiden, Netherlands
Research Site
Veldhoven, Netherlands
Research Site
Venlo, Netherlands
Research Site
Zutphen, Netherlands
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01103089     History of Changes
Other Study ID Numbers: NIS-ONL-IRE-2009/1
Study First Received: April 5, 2010
Last Updated: October 11, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by AstraZeneca:
NSCLC
EGFR
gefitinib
observational

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial 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 June 18, 2013