At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma
- ✓Radiographic evidence of one or more bone lesions (or lytic lesions in myeloma)
- ✓Currently receiving IV bisphosphonates
- ✓Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine
- ✕More than 2 prior skeletal-related events (SRE)
- ✕Known brain metastases
- ✕Prior history or current evidence of osteonecrosis or osteomyelitis of the jaw
- ✕Active dental or jaw conditions requiring oral surgery or non-healed dental/oral surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates
In Brief
A Phase 2 clinical trial evaluating AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, and 1 other intervention for Bone Metastases in Men With Hormone-Refractory Prostate Cancer and 2 related conditions. Completed, enrolled 111 participants.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.