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

PHASE2CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

January 31, 2008

Study Completion Date

March 31, 2010

Conditions
Bone Metastases in Men With Hormone-Refractory Prostate CancerBone Metastases in Subjects With Advanced Breast CancerBone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Interventions
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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY