This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

August 22, 2016 updated by: Genzyme, a Sanofi Company

A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.

The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

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
      • Buenos Aires, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Brussels (Jette), Belgium
        • Research Site
      • Brussels (Woluwé-St-Lambert), Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Wilrijk, Belgium
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany
        • Research Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany
        • Research Site
    • Sunderland
      • Ryhope, Sunderland, Germany
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Lyttelton Manor, South Africa
        • Research Site
      • Parktown, South Africa
        • Research Site
      • Port Elizabeth, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • United Kingdom
      • Edinburgh, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom
        • Research Site
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom
        • Research Site
  • United States
    • Arkansas
      • Pine Bluff, Arkansas, United States
        • Research Site
    • California
      • Los Angeles, California, United States
        • Research Site
      • Palm Springs, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Orange Park, Florida, United States
        • Research Site
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Missouri
      • St. Loius, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Greenville, North Carolina, United States
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
  • Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion Criteria:

  • Subjects who have received second-line or subsequent chemotherapy
  • Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)

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: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary Outcomes:
Part A
i. Time to progression
ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
Part B

Secondary Outcome Measures

Outcome Measure
Part A
Part B
Secondary Outcomes:
i. Objective response
ii. Disease control at 8 weeks
iii. Time to death
iv. WHO performance status
v. QOL and LCS from the FACT-L questionnaire
i. Objective response in subjects following treatment with the alternate study treatment
ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
iii. WHO performance status in subjects following treatment with the alternate study treatment
iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment

Collaborators and Investigators

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

Sponsor

Genzyme, a Sanofi Company

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

May 1, 2003

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 2, 2003

First Submitted That Met QC Criteria

May 2, 2003

First Posted (Estimate)

May 5, 2003

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6474IL/0003

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.

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