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

Primary Purpose

Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZD6474
Placebo
Docetaxel
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

Outcome Progression free survival

Secondary Outcome Measures

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
Time to death

Full Information

First Posted
October 18, 2002
Last Updated
August 24, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00047840
Brief Title
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
129 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ZD6474
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
Outcome Progression free survival
Secondary Outcome Measure Information:
Title
Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
Title
Objective response rate and duration of response
Title
QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
Title
WHO performance status
Title
Time to death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Pittsfield
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Billings
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Coos Bay
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Chomutov
Country
Czech Republic
Facility Name
Research Site
City
Hradec
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
Country
Czech Republic
Facility Name
Research Site
City
Plzen
Country
Czech Republic
Facility Name
Research Site
City
Praha
Country
Czech Republic
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Deszk
Country
Hungary
Facility Name
Research Site
City
Torokbalint
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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

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