CompletedPhase 2

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

United States, Australia, Canada19 participantsStarted 2006-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Objective Response Rate (ORR)

Timeframe: RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.

Trial details

NCT IDNCT00358956

SponsorGenzyme, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

Results submitted2011-04-27

View on ClinicalTrials.gov More Thyroid Cancer trials