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

Genzyme

Status and phase: Completed; Phase 2

Conditions: Thyroid Cancer

Treatments: Drug: ZD6474 (vandetanib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00358956

2006-001354-28 (EudraCT Number)

D4200C00068

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ZD6474 (vandetanib)