NCT00104650

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.

Conditions

• Bone Metastases in Men With Hormone-Refractory Prostate Cancer
• Bone Metastases in Subjects With Advanced Breast Cancer
• Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Interventions

Type	Name	Description
GENETIC	AMG 162 180 mg (SC) q 12 weeks	A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.
DRUG	IV Bisphosphonate q 4 weeks	IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.
GENETIC	AMG 162- 180 mg q 4 weeks	A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-01-01
• Completion: 2010-03-01
• First posted: 2005-03-04
• Last updated: 2011-01-24
• Results posted: 2011-01-07