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

AstraZeneca10 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-Small Cell Lung Cancer

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Participation in the gefitinib Expanded Access Program * Patient still uses gefitinib in September 2009

Locations (11)

Research Site

Amsterdam, Netherlands

Research Site

Apeldoorn, Netherlands

Research Site

Groningen, Netherlands

Research Site

Helmond, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

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)

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.