Sorafenib vs Placebo in Thyroid Cancer

• Research type

  Research Study

• Full title

  A Double-Blind, Randomised Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

• IRAS ID

  31179

• Contact name

  Chris Nutting

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2009-012007-25

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  This study is focusing on patients who are suffering from a certain form of thyroid cancer. These patients have advanced disease for which there is no cure available, and have not responded positively to existing standard treatments, in particular treatment with Radioactive Iodine. As the cancer in these patients is advanced new treatment options are urgently needed. Sorafenib (marketed as Nexavar©) is currently available for the treatment of liver and kidney cancer and works by stopping the growth and development of new cancer cells, it is hoped that sorafenib might become a new treatment standard for this patient group. Around 380 patients worldwide will be randomly assigned in a 1:1 fashion and will receive either sorafenib or placebo until disease progression or unacceptable toxicity occurs. After disease progression patients that previously received placebo can cross over to receive sorafenib. The primary endpoint of this trial will be progression-free-survival, i.e. to see whether treatment with sorafenib will prolong time until growth of tumour compared to placebo treatment (containing no active medication). ;

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  09/H1107/107

• Date of REC Opinion

  9 Apr 2010

• REC opinion

  Further Information Favourable Opinion