Open Label, Phase I ZD6474 Head and Neck Cancer Study

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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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Denver, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD6474 (Vandetanib)

Drug

once daily oral dose

Other names: ZACTIMA™

Cisplatin

Drug

intravenous infusion

Radiation

radiation of head and neck

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2011
First posted: Mar 21, 2007
Registry last updated: Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed