Open Label, Phase I ZD6474 Head and Neck Cancer Study

Phase 1

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: ZD6474 (vandetanib); Drug: Cisplatin; Radiation: Radiation

• Registration Number: NCT00450138
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Primary Completion: 2009-11
• Study Completion: 2011-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Stage III-IV squamous cell carcinoma of the head and neck

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Exclusion Criteria

• No previous treatment for head and neck cancer, adequate cardiac function

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Radiation	Radiation + cisplatin + vandetanib
1	ZD6474 (vandetanib)	Radiation + vandetanib
1	Radiation	Radiation + vandetanib
2	ZD6474 (vandetanib)	Radiation + cisplatin + vandetanib
2	Cisplatin	Radiation + cisplatin + vandetanib

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Houston, Texas, United States