CAPRELSA

• Research type

  Research Study

• Full title

  European, Observational, Prospective Study to Evaluate the Benefit/Risk of Vandetanib (CAPRELSA™) 300 mg in RET Mutation Negative and RET Mutation Positive Patients with Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer (MTC)

• IRAS ID

  132658

• Contact name

  Kate Newbold

• Contact email

  Kate.Newbold@rmh.nhs.uk

• Sponsor organisation

  Genzyme-Sanofi Corporation

• Duration of Study in the UK

  2 years, 10 months, 9 days

• Research summary

  This study is being performed to fulfil specific requirements as a measure to be granted the approval of vandetanib (CAPRELSA™) 300 mg being marketed. It will confirm the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in patients with a type of thyroid cancer. The benefits of vandetanib (CAPRELSA™) 300 mg have previously been established in a clinical trial (Study 58). There will be no extra procedures and standard of care will be followed. European countries where vandetanib is on the market will participate in the study. The study will be performed in approximately 9 countries in Europe.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  14/LO/0279

• Date of REC Opinion

  26 Feb 2014

• REC opinion

  Favourable Opinion