NCT00298688

Brief Summary

The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib

Trial Health

90
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Geographic Reach
2 countries

3 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

September 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

June 12, 2008

Status Verified

June 1, 2008

First QC Date

March 1, 2006

Last Update Submit

June 11, 2008

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the disease control rate in these patients

Secondary Outcomes (3)

  • To determine the objective response rate at trail closure in these patients

  • To determine the time to progression-or-death in these patients

  • To determine overall survival in these patients

Interventions

GefitinibDRUG

Eligibility Criteria

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

You may qualify if:

  • Provision of written informed consent
  • Histologically confirmed, relapsed or refractory SCLCr
  • Aged 18 or over and a life expectancy of more than 2 months

You may not qualify if:

  • Any evidence of clinically active interstitial lung disease
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Copenhagen, Denmark

Location

Research Site

Herlev, Denmark

Location

Research Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

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 Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 3, 2006

Study Start

September 1, 2004

Study Completion

March 1, 2007

Last Updated

June 12, 2008

Record last verified: 2008-06

Locations

DK(2)GB(1)