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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab; Diphosphonates

Criteria

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.