ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
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)
3 other identifiers
interventional
N/A
9 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2004
Typical duration for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2003
CompletedFirst Posted
Study publicly available on registry
October 16, 2003
CompletedStudy Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedAugust 25, 2016
August 1, 2016
3.7 years
October 14, 2003
August 24, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Research Site
Concord, California, United States
Research Site
Los Angeles, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
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Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Norfolk, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Helsinki, Finland
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Turku, Finland
Research Site
Besançon, France
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Lille, France
Research Site
Strasbourg, France
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Essen, Germany
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Frankfurt, Germany
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Mainz, Germany
Research Site
Ulm, Germany
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Pune, India
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Milan, Italy
Research Site
Orbassano, Italy
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Cape Town, South Africa
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Johannesburg, South Africa
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Panorama, South Africa
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Parkland, South Africa
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Pretoria, South Africa
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
Research Site
Chiang Mai, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2003
First Posted
October 16, 2003
Study Start
February 1, 2004
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
August 25, 2016
Record last verified: 2016-08