Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

April 22, 2009 updated by: AstraZeneca

A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen

This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1692

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
        • Research Site
      • Buenos Aires, Argentina
        • Research Site
      • La Plata, Argentina
        • Research Site
      • Mar del Plata, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
        • Research Site
  • Australia
      • Woodville South, Australia
        • Research Site
    • New South Wales
      • Concord, New South Wales, Australia
        • Research Site
      • Potts Point, New South Wales, Australia
        • Research Site
      • St. Leonards, New South Wales, Australia
        • Research Site
    • Queensland
      • Chermside, Queensland, Australia
        • Research Site
      • South Brisbane, Queensland, Australia
        • Research Site
    • South Australia
      • Ashford, South Australia, Australia
        • Research Site
      • Woodville, South Australia, Australia
        • Research Site
    • Victoria
      • Melbourne, Victoria, Australia
        • Research Site
      • Parkville, Victoria, Australia
        • Research Site
      • Prahran, Victoria, Australia
        • Research Site
      • Wodonga, Victoria, Australia
        • Research Site
  • Brazil
    • CE
      • Fortaleza, CE, Brazil
        • Research Site
    • MG
      • Belo Horizonte, MG, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
      • Sorocaba, SP, Brazil
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
      • Veliko Tarnovo, Bulgaria
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • New Brunswick
      • Monoton, New Brunswick, Canada
        • Research Site
    • Ontario
      • Mississauga, Ontario, Canada
        • Research Site
      • Newmarket, Ontario, Canada
        • Research Site
      • St. Catherines, Ontario, Canada
        • Research Site
      • Sudbury, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • York, Ontario, Canada
        • Research Site
    • Quebec
      • Laval, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Ste-Foy, Quebec, Canada
        • Research Site
  • Chile
      • Various Cities, Chile
        • Research Site
  • Estonia
      • Talinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Germany
      • Frankfurt, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Gauting, Germany
        • Research Site
      • Grobhansdorf, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Hemer, Germany
        • Research Site
      • Muchen, Germany
        • Research Site
    • Baden-Wurttemberg
      • Freiburg, Baden-Wurttemberg, Germany
        • Research Site
      • Heidelberg, Baden-Wurttemberg, Germany
        • Research Site
    • Bayern
      • Muchen, Bayern, Germany
        • Research Site
    • Hessen
      • Frankfurt, Hessen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Munster, Nordrhein-Westfalen, Germany
        • Research Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Heraklion, Greece
        • Research Site
      • Marousi, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Deszk, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Mosdos, Hungary
        • Research Site
      • Mosonmagyarovar, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Torokbalint, Hungary
        • Research Site
      • Ujronafj, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
      • Zalaegerszeg-Pozva, Hungary
        • Research Site
  • India
      • India, India
        • Research Site
      • Karnataka, India
        • Research Site
      • Kolkata, India
        • Research Site
      • Vellore, India
        • Research Site
  • Ireland
      • Beaumont Road, Ireland
        • Research Site
      • Cork, Ireland
        • Research Site
      • Dublin 7, Ireland
        • Research Site
      • Dublin 8, Ireland
        • Research Site
      • Elm Park, Ireland
        • Research Site
    • Limerick
      • Dooradoyle, Limerick, Ireland
        • Research Site
  • Latvia
      • Daugavpils, Latvia
        • Research Site
      • Liepaja, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Nilai, Malaysia
        • Research Site
      • Penang, Malaysia
        • Research Site
  • Mexico
      • Acapulco, Mexico
        • Research Site
      • Durango, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Leon, Mexico
        • Research Site
      • Mexico, Mexico
        • Research Site
    • Coahuila
      • Torreon, Coahuila, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
    • Neuvo Leon
      • Monterrey, Neuvo Leon, Mexico
        • Research Site
    • Yucatan
      • Merida, Yucatan, Mexico
        • Research Site
  • Netherlands
      • Alkmaar, Netherlands
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Enschede, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
  • Norway
      • Alesund, Norway
        • Research Site
      • Bergen, Norway
        • Research Site
      • Gjettum, Norway
        • Research Site
      • Hamar, Norway
        • Research Site
      • Haugesund, Norway
        • Research Site
      • Kristiansand, Norway
        • Research Site
      • Nordbyhagen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Skien, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Tromso, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Peru
      • Various Cities, Peru
        • Research Site
  • Philippines
      • Manila, Philippines
        • Research Site
      • Pasig, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Gdansk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
  • Romania
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj Napoca, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Dolny Kubin, Slovakia
        • Research Site
      • Jilina, Slovakia
        • Research Site
      • Kojice, Slovakia
        • Research Site
      • Martin, Slovakia
        • Research Site
      • Michalovce, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Nitra-Zobor, Slovakia
        • Research Site
      • Nove Zamky, Slovakia
        • Research Site
      • Poprad, Slovakia
        • Research Site
      • Poprad - Kvetnica, Slovakia
        • Research Site
      • Prejov, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
  • Sweden
      • Goteborg, Sweden
        • Research Site
      • Huddinge, Sweden
        • Research Site
      • Jonkoping, Sweden
        • Research Site
      • Karlstad, Sweden
        • Research Site
      • Linkoping, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
    • Vastmanlands Lan
      • Vasteras, Vastmanlands Lan, Sweden
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-Yuan, Taiwan
        • Research Site
    • Taipei
      • Pan-Chiao, Taipei, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
  • Ukraine
      • Various Cities, Ukraine
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Research Site
      • Birmingham, United Kingdom
        • Research Site
      • Bradford, United Kingdom
        • Research Site
      • Brighton, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Essex, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Guildford, United Kingdom
        • Research Site
      • Gwynedd, United Kingdom
        • Research Site
      • Harrogate, United Kingdom
        • Research Site
      • Huddersfield, United Kingdom
        • Research Site
      • Hull, United Kingdom
        • Research Site
      • Lancaster, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Newcastle-upon-Tyne, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
      • Reading, United Kingdom
        • Research Site
      • Southampton, United Kingdom
        • Research Site
      • Swansea, United Kingdom
        • Research Site
      • Wolverhampton, United Kingdom
        • Research Site
      • York, United Kingdom
        • Research Site
    • Cambrideshire
      • Cambridge, Cambrideshire, United Kingdom
        • Research Site
    • Devon
      • Exeter, Devon, United Kingdom
        • Research Site
    • Essex
      • Colchester, Essex, United Kingdom
        • Research Site
      • Romford, Essex, United Kingdom
        • Research Site
    • Great Yarmouth
      • Gorleston, Great Yarmouth, United Kingdom
        • Research Site
    • Lanc
      • Fulwood, Lanc, United Kingdom
        • Research Site
    • Norfolk
      • Norwich, Norfolk, United Kingdom
        • Research Site
    • Northamptonshire
      • Nottingham, Northamptonshire, United Kingdom
        • Research Site
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom
        • Research Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Research Site
  • Venezuela
      • Various Cities, Venezuela
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • · Life expectancy of at least 8 weeks.

    • Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
    • Not suitable for chemotherapy
    • WHO Performance status 0,1, 2 or 3

Exclusion Criteria:

  • Newly diagnosed CNS mets
  • Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
  • ALT/AST greater than 5 x upper limit of normal
  • ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
· ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
· ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
· objective tumour response (CR + PR)
· ZD1839 + BSC versus Placebo + BSC in terms of tolerability
· ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: AstraZeneca Oncology Medical Science Direction, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1839IL/0709
  • ISEL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings