NCT00255489

Brief Summary

The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2004

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

First QC Date

November 17, 2005

Last Update Submit

January 24, 2011

Conditions

Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To characterize the safety profile of ZD 1839 in these patients

Secondary Outcomes (2)

  • To measure the quality of life compared to baseline

  • To measure the change in disease related symptoms compared to baseline

Interventions

GefitinibDRUG
palliative thoracic radiotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of written informed consent
  • Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2
  • Histologically or cytologically conformed non-small cell lung cancer
  • Aged 18 or over

You may not qualify if:

  • Previous thoracic radiotherapy
  • Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event
  • Known hypersensitivity to any component of study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Edinburgh, United Kingdom

Location

Research Site

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Iressa Medical Sciences Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

May 1, 2004

Study Completion

June 1, 2006

Last Updated

January 25, 2011

Record last verified: 2011-01

Locations

GB(2)