Back to resultsOpen Label, Phase I ZD6474 Head and Neck Cancer Study
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ZD6474 (vandetanib)
Cisplatin
Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Stage III-IV squamous cell carcinoma of the head and neck
Exclusion Criteria:
- No previous treatment for head and neck cancer, adequate cardiac function
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Radiation + vandetanib
Radiation + cisplatin + vandetanib
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose of vandetanib given in combination with radiation or radiation and chemotherapy in patients with late stage head and neck cancer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00450138
Brief Title
Open Label, Phase I ZD6474 Head and Neck Cancer Study
Official Title
An Open Label Phase 1 Study to Assess the Maximum Tolerated Dose of ZACTIMA™ Given Concomitantly With Weekly Cisplatin Chemotherapy and Radiation Therapy in Patients With Previously Untreated, Unresected Stage III-IV Head and Neck Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in combination with radiation or in combination with chemotherapy and radiation in patients with squamous cell carcinoma of the head and neck.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Radiation + vandetanib
Arm Title
2
Arm Type
Experimental
Arm Description
Radiation + cisplatin + vandetanib
Intervention Type
Drug
Intervention Name(s)
ZD6474 (vandetanib)
Other Intervention Name(s)
ZACTIMA™
Intervention Description
once daily oral dose
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
intravenous infusion
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
radiation of head and neck
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose of vandetanib given in combination with radiation or radiation and chemotherapy in patients with late stage head and neck cancer
Time Frame
assessed at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III-IV squamous cell carcinoma of the head and neck
Exclusion Criteria:
No previous treatment for head and neck cancer, adequate cardiac function
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
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1431&filename=CSR-D4200C00062.pdf
Description
CSR-D4200C00062.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1431&filename=D4200C00062_Clinical_study_revised_protocol_redacted_[SECURE].pdf
Description
protocol redacted
Learn more about this trial
Open Label, Phase I ZD6474 Head and Neck Cancer Study
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