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Open Label, Phase I ZD6474 Head and Neck Cancer Study

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00450138
Collaborator
(none)
48
Enrollment
4
Locations
2
Arms
59
Duration (Months)
12
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Radiation + vandetanib

Drug: ZD6474 (vandetanib)
once daily oral dose
Other Names:
  • ZACTIMA™

    • Radiation: Radiation
    radiation of head and neck
    Experimental: 2

    Radiation + cisplatin + vandetanib

    Drug: ZD6474 (vandetanib)
    once daily oral dose
    Other Names:
  • ZACTIMA™

    • Drug: Cisplatin
    intravenous infusion

    Radiation: Radiation
    radiation of head and neck

    Outcome Measures

    Primary Outcome Measures

    1. 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 [assessed at each visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Denver Colorado United States
    2 Research Site Chicago Illinois United States
    3 Research Site Dallas Texas United States
    4 Research Site Houston Texas United States

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT00450138
    Other Study ID Numbers:
    • D4200C00062
    • NCT00411710
    First Posted:
    Mar 21, 2007
    Last Update Posted:
    Aug 29, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Sanofi
    Squamous Cell Carcinoma
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Cisplatin

    Study Results

    No Results Posted as of Aug 29, 2016