ZD6474 Phase IIa Dose Finding Multicentre Study
A Randomised, Double-blind, Parallel-group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]
1 other identifier
interventional
53
1 country
7
Brief Summary
To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2004
7 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
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedAugust 25, 2016
August 1, 2016
2.1 years
November 14, 2005
August 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively
Every 4 weeks for the first 24 weeks of treatment and then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response
Secondary Outcomes (1)
To assess the tolerability, safety, disease control rate, duration of response, time to progression, changes in quality of life and tumour-related and overall symptom improvements, and to characterise the PK and PK-PD relationship
Every 4 weeks till meeting discontinuation criteria
Study Arms (3)
ZD6474 100mg
EXPERIMENTALDaily dose
ZD6474 200mg
EXPERIMENTALdaily dose
ZD6474 300mg
EXPERIMENTALdaily dose
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written informed consent.
- Life expectancy of 12 weeks or longer.
You may not qualify if:
- Pregnancy, breast feeding or female patients wishing to become pregnant.
- Treatment with a non-approved or investigational drug within 30 days before enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Research Site
Matsuyama, Ehime, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Sayama, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Tokyo, Japan
Related Publications (1)
Kiura K, Nakagawa K, Shinkai T, Eguchi K, Ohe Y, Yamamoto N, Tsuboi M, Yokota S, Seto T, Jiang H, Nishio K, Saijo N, Fukuoka M. A randomized, double-blind, phase IIa dose-finding study of Vandetanib (ZD6474) in Japanese patients with non-small cell lung cancer. J Thorac Oncol. 2008 Apr;3(4):386-93. doi: 10.1097/JTO.0b013e318168d228.
PMID: 18379357BACKGROUND
MeSH Terms
Conditions
Interventions
Condition 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
November 14, 2005
First Posted
November 15, 2005
Study Start
December 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
August 25, 2016
Record last verified: 2016-08