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

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.

Inclusion Criteria:

• Patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma
• Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma
• Currently receiving IV bisphosphonates
• Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine
• Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

Exclusion Criteria:

• More than 2 prior skeletal related events (SRE)
• Known brain metastases
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
• Active dental or jaw conditions which requires oral surgery
• Non-healed dental/oral surgery
• Prior administration of AMG 162
• Evidence of impending fracture in weight bearing bones
• Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the study.