NCT00234442

Brief Summary

The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

4 active sites

Status
terminated

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

July 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

First QC Date

October 5, 2005

Last Update Submit

June 29, 2009

Conditions

Brain NeoplasmsNon Small Cell Lung Cancer

Keywords

Non symptomatic brain metastasesIressa

Outcome Measures

Primary Outcomes (1)

  • Disease control rate (complete response, partial response and stable disease)

Secondary Outcomes (3)

  • Duration of response

  • Time to progression

  • Overall Survival

Interventions

Iressa (Gefitinib)DRUG

Eligibility Criteria

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

You may qualify if:

  • Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
  • No symptoms due to brain metastases
  • No previous radiotherapy treatment for the Brain metastases

You may not qualify if:

  • No prior chemotherapy
  • No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Bologna, Italy

Location

Research Site

Orbassano, Italy

Location

Research Site

Parma, Italy

Location

Research Site

Rozzano, Italy

Location

MeSH Terms

Conditions

Brain NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Lucio Crino, MD

    Bologna, Italy

    PRINCIPAL INVESTIGATOR

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

October 5, 2005

First Posted

October 7, 2005

Study Start

July 1, 2004

Study Completion

February 1, 2006

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

IT(4)