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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103089
• Other study ID #: NIS-ONL-IRE-2009/1
• Status: Completed
• Phase: N/A
• First received: April 5, 2010
• Last updated: October 11, 2011
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participation in the gefitinib Expanded Access Program

• Patient still uses gefitinib in September 2009

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	Yes
Secondary	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)	No
Secondary	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)	No