MedTrace Logo

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

NCT00104650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2011-01-24

Study results available
· View outcomes & findings →

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

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 & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-01-31
Completion
2010-03-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00104650 on ClinicalTrials.gov