NCT00450138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Dec 2006

Typical duration for phase_1 head-and-neck-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

March 20, 2007

Last Update Submit

August 26, 2016

Conditions

Head and Neck Cancer

Keywords

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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

Study Arms (2)

1

EXPERIMENTAL

Radiation + vandetanib

Drug: ZD6474 (vandetanib)Radiation: Radiation

2

EXPERIMENTAL

Radiation + cisplatin + vandetanib

Drug: ZD6474 (vandetanib)Drug: CisplatinRadiation: Radiation

Interventions

ZD6474 (vandetanib)DRUG

once daily oral dose

Also known as: ZACTIMA™
12
CisplatinDRUG

intravenous infusion

2
RadiationRADIATION

radiation of head and neck

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Denver, Colorado, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Dallas, Texas, United States

Location

Research Site

Houston, Texas, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

vandetanibCisplatinRadiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhysical Phenomena

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2011

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

US(4)