Vandetanib in Patients with Medullary Thyroid Cancer

• Research type

  Research Study

• Full title

  A Randomized, International, Open-Label, Multi-Centre, Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients with Locally Advanced or Metastatic Medullary Thyroid Cancer Experience Grade 2 or Higher Adverse Events during the First 12 Months of Treatment with Vandetanib

• IRAS ID

  67549

• Contact name

  Kate Newbold

• Contact email

  Kate.Newbold@rmh.nhs.uk

• Sponsor organisation

  Sanofi Genzyme BV Europe

• Eudract number

  2010-023428-26

• Duration of Study in the UK

  5 years, 6 months, 30 days

• Research summary

  AstraZeneca is conducting a global research study with Vandetanib, an anticancer agent, in patients with medullary thyroid cancer. This study will examine whether regular contact with a healthcare professional allows early intervention resulting in better management of side effects.

  Once patients have undergone the screening assessments and are confirmed as suitable for the study, patients will be split into two groups at random; both will attend the hospital for regular clinic visits but half will also be frequently contacted at home by a healthcare professional during the first year of treatment. Both groups can contact the hospital at any time for advice. All patients will receive Vandetanib.

  All patients will attend the hospital on 10 separate occasions during the first year of treatment. The study visits will be most frequent during the first 6 months. Half the patients will have additional contact at home every 2 weeks during the first year of treatment. Patients can remain on Vandetanib for as long as they are receiving clinical benefit and are not experiencing unacceptable side effects. After taking Vandetanib for 1 year, patients who choose to continue Vandetanib will be contacted every 13 weeks for safety purposes. For patients who decide to stop Vandetanib at any time, further treatment will be at the discretion of the responsible clinical team, based on local and national guidelines.

  The study plans to recruit 8 patients in the UK with a total of 154 patients globally from 45 centres.

• REC name

  Scotland B REC

• REC reference

  11/AL/0134

• Date of REC Opinion

  30 Mar 2011

• REC opinion

  Favourable Opinion