This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.
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.
1 other identifier
interventional
129
3 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2002
Typical duration for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 18, 2002
CompletedFirst Posted
Study publicly available on registry
October 24, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedAugust 25, 2016
August 1, 2016
October 18, 2002
August 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Outcome Progression free survival
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
- Failure of first-line platinum-based chemotherapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Research Site
Los Angeles, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Pittsfield, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Billings, Montana, United States
Research Site
Great Neck, New York, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Coos Bay, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
Brno, Czechia
Research Site
Chomutov, Czechia
Research Site
Hradec, Czechia
Research Site
Ostrava, Czechia
Research Site
Pilsen, Czechia
Research Site
Prague, Czechia
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Deszk, Hungary
Research Site
Törökbálint, Hungary
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2002
First Posted
October 24, 2002
Study Start
October 1, 2002
Study Completion
September 1, 2006
Last Updated
August 25, 2016
Record last verified: 2016-08