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NCT00450138 Clinical Trial

Open Label, Phase I ZD6474 Head and Neck Cancer Study

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00450138
Other study ID # D4200C00062
Secondary ID
Status Completed
Phase Phase 1
First received March 20, 2007
Last updated August 26, 2016
Start date December 2006
Est. completion date November 2011

Study information
Verified date August 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00411710

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date November 2011
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ZD6474 (vandetanib)
once daily oral dose
• Cisplatin
intravenous infusion
Radiation:
• Radiation
radiation of head and neck

Locations
Country Name City State
United States Research Site Chicago Illinois
United States Research Site Dallas Texas
United States Research Site Denver Colorado
United States Research Site Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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