20080540 Open Label Extension Study with Denosumab in Bone Metastases.

• Research type

  Research Study

• Full title

  An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma.

• IRAS ID

  23465

• Contact name

  Charles Brigden

• Sponsor organisation

  Amgen

• Eudract number

  2009-009374-27

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Bone is the most frequent site for cancer metastases, which are cancer cells that have broken away from the primary tumour and travelled in the blood stream to settle down and grow elsewhere in the body. Bone metastases are a common reason for pain reported in cancer patients and they often lead to debilitating complications such as skeletal related events (SRE), which include pathologic fractures (when a bone breaks in an area weakened by a tumour), need for radiation therapy or surgery to bone, and spinal cord compression. The normal turnover of bone is controlled by cells that breakdown and remove bone. In patients with bone metastases, this breakdown and removal of bone is increased. Denosumab inhibits bone loss by inhibiting the activity of cells that break down and remove bone. By preventing this breakdown it is possible we could delay and inhibit the occurrence of SREs related to bone metastases. Denosumab is currently being investigated in this setting in the phase 3 studies 20050103, 20050136 and 20050244 where the bisphosphonate zoledronic acid is being used as an active comparator. Patients who are currently participating in these phase 3 studies will be offered this study if denosumab is found to be at least as good as or better than zoledronic acid in their respective study. Patients will be offered denosumab until they have access to commercially available product or for up to 2 years, whichever comes first. The main purpose of this study is to provide long term information on the safety and tolerability of denosumab as a treatment for bone metastases in patients with advanced cancer or multiple myeloma (cancer that develops from plasma cells in the bone marrow) who previously received either zoledronic acid or denosumab. It will also allow access to denosumab for those patients that received zoledronic acid in the previous study.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/31

• Date of REC Opinion

  7 Aug 2009

• REC opinion

  Further Information Favourable Opinion