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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01103089

Enrollment

Registered

2010-04-14

Start date

2010-03-31

Completion date

2010-12-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC, EGFR, gefitinib, observational

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.	Characteristics will be recorded once, retrospectively

Secondary

Measure	Time frame
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	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	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	Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)

Countries

Netherlands

Outcome results