A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2014-05-31

Brief Summary

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This will be a Phase II, open label study to establish the effect of once-daily oral doses of ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid cancer in whom no standard therapeutic option is available.

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Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ZD6474 (vandetanib)

Intervention Type DRUG

100 mg once daily oral tablet

Interventions

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ZD6474 (vandetanib)

100 mg once daily oral tablet

Intervention Type DRUG

Other Intervention Names

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Caprelsa™

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent
* Previously confirmed histological diagnosis of locally advanced or metastatic hereditary medullary thyroid carcinoma without standard therapeutic options
* Aged 18 or over and a life expectancy of more than 12 weeks

Exclusion Criteria

* The last dose of prior chemo/radiation received less than 4 weeks before the start of study therapy
* Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age, history of arrhythmia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No