Nintedanib, placebo and Best Supportive Care in Colorectal Cancer.

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo controlled Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer refractory to standard therapies.

• IRAS ID

  155996

• Contact name

  Leslie Samuel

• Contact email

  leslie.samuel@nhs.net

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2012-000095-42

• Research summary

  This study is a double-blind, randomised, placebo controlled Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer refractory to standard therapies. Eligible patients will be stratified by 1) Previous treatment with regorafenib (yes vs. no) 2) Time from onset of metastatic disease until randomisation in the trial (less than 24 months vs. 24 months or more) and 3) Region (Western Europe and North America and Australia, Asia, rest of the world). It is hoped to enroll approximately 800 patients with a view to randomise 764 in 24 countries.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  14/ES/1001

• Date of REC Opinion

  27 Jun 2014

• REC opinion

  Further Information Favourable Opinion