Extension study of Denosumab in patients with advanced cancer

• Research type

  Research Study

• Full title

  Open-Label Access Protocol of Denosumab for Subjects with Advanced Cancer

• IRAS ID

  85217

• Contact name

  Anne Armstrong

• Sponsor organisation

  Amgen Inc

• Eudract number

  2011-002114-36

• Research summary

  Subjects who will be asked to consider taking part in this study are patients who have participated in a previous denosumab study, and whose doctor may think it is beneficial to continue on this treatment. The purpose of this research study is to allow subjects to continue denosumab treatment. Once this study ends, the subject??s doctor will be responsible for obtaining denosumab if they feel it is still required. Denosumab is an antibody that might delay complications related to bone metastases such as pain or fracture. All subjects will receive denosumab at a dose of 120mg under the skin, every 4 weeks until the end of the study or until the study doctor decides the patient should stop treatment while on the study. It is anticipated that the treatment duration for this study will be approximately 1 year. The patient and study doctor will know that they are receiving denosumab.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0603

• Date of REC Opinion

  10 Oct 2011

• REC opinion

  Further Information Favourable Opinion