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Open Label, Phase I ZD6474 Head and Neck Cancer Study

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ClinicalTrials.gov Identifier: NCT00450138
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

March 20, 2007
March 21, 2007
August 29, 2016
December 2006
November 2009   (Final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00450138 on ClinicalTrials.gov Archive Site
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Open Label, Phase I ZD6474 Head and Neck Cancer Study
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
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.
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Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: ZD6474 (vandetanib)
    once daily oral dose
    Other Name: ZACTIMA™
  • Drug: Cisplatin
    intravenous infusion
  • Radiation: Radiation
    radiation of head and neck
  • Experimental: 1
    Radiation + vandetanib
    Interventions:
    • Drug: ZD6474 (vandetanib)
    • Radiation: Radiation
  • Experimental: 2
    Radiation + cisplatin + vandetanib
    Interventions:
    • Drug: ZD6474 (vandetanib)
    • Drug: Cisplatin
    • Radiation: Radiation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
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November 2011
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00450138
D4200C00062
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Sanofi
Sanofi
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Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP