This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.

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

A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

129

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

  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Chomutov, Czech Republic
        • Research Site
      • Hradec, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Deszk, Hungary
        • Research Site
      • Torokbalint, Hungary
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States
        • Research Site
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
      • Pittsfield, Massachusetts, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Detroit, Michigan, United States
        • Research Site
    • Montana
      • Billings, Montana, United States
        • Research Site
    • New York
      • Great Neck, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States
        • Research Site
    • Oregon
      • Coos Bay, Oregon, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Texas
      • Houston, Texas, 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:

  • Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
  • Failure of first-line platinum-based chemotherapy

Exclusion Criteria:

  • Mixed small cell or non-small-cell histology
  • Bronchoalveolar carcinoma
  • Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
  • Prior treatment with docetaxel

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

Outcome Measure
Outcome Progression free survival

Secondary Outcome Measures

Outcome Measure
Time to death
Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
Objective response rate and duration of response
QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
WHO performance status

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

October 1, 2002

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

October 18, 2002

First Submitted That Met QC Criteria

October 23, 2002

First Posted (Estimate)

October 24, 2002

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6474IL/0006

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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