This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.
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.
1 other identifier
interventional
160
6 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2003
Typical duration for phase_2
48 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
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 2, 2003
CompletedFirst Posted
Study publicly available on registry
May 5, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedAugust 24, 2016
August 1, 2016
May 2, 2003
August 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (12)
Secondary Outcomes:
Part A
i. Objective response
ii. Disease control at 8 weeks
iii. Time to death
- +7 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Research Site
Pine Bluff, Arkansas, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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San Diego, California, United States
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Boca Raton, Florida, United States
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Jacksonville, Florida, United States
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Orange Park, Florida, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Shreveport, Louisiana, United States
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Saint Loius, Missouri, United States
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St Louis, Missouri, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Greenville, North Carolina, United States
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Bismarck, North Dakota, United States
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Madison, Wisconsin, United States
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Buenos Aires, Argentina
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Mendoza, Argentina
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Brussels, Belgium
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Brussels (Jette), Belgium
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Brussels (Woluwé-St-Lambert), Belgium
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Edegem, Belgium
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Liège, Belgium
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Wilrijk, Belgium
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Hamburg, Hamburg, Germany
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Essen, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Berlin, State of Berlin, Germany
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Ryhope, Sunderland, Germany
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Berlin, Germany
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Essen, Germany
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Hamburg, Germany
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Mainz, Germany
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Bloemfontein, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Lyttelton Manor, South Africa
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Parktown, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Northwood, Middlesex, United Kingdom
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Cardiff, South Glamorgan, United Kingdom
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Edinburgh, United Kingdom
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Leeds, United Kingdom
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Manchester, United Kingdom
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
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2003
First Posted
May 5, 2003
Study Start
May 1, 2003
Study Completion
June 1, 2007
Last Updated
August 24, 2016
Record last verified: 2016-08