ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

August 24, 2016 updated by: Genzyme, a Sanofi Company

A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Finland
      • Helsinki, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • France
      • Besancon, France
        • Research Site
      • Lille, France
        • Research Site
      • Strasbourg, France
        • Research Site
  • Germany
      • Essen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
  • India
      • Pune, India
        • Research Site
  • Italy
      • Milano, Italy
        • Research Site
      • Orbassano, Italy
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Panorama, South Africa
        • Research Site
      • Parkland, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Pamplona, Spain
        • Research Site
  • Thailand
      • Chiang mai, Thailand
        • Research Site
  • United States
    • California
      • Concord, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, 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:

  • Signed informed consent
  • 18 years or older
  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC
  • No prior chemotherapy/biological therapy/radiation therapy
  • One or more measurable lesions
  • Life expectancy more than 12 weeks

Exclusion Criteria:

  • Brain metastases or spinal cord compression
  • Currently active skin disease
  • History of significant hemoptysis
  • Abnormal blood chemistry
  • Cardiac abnormalities
  • Recent significant cardiac event
  • Coexisting malignancies

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: Quadruple

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

February 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 14, 2003

First Submitted That Met QC Criteria

October 15, 2003

First Posted (Estimate)

October 16, 2003

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200C00007
  • D4200C00007(run-in)
  • D4200C0007A (randomization)

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.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe