A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates

NCT00104650 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Amgen
Phase	Phase 2
Status	COMPLETED
Enrolment	111
Start date	2005-01
Completion	2010-03

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

• AMG 162 180 mg (SC) q 12 weeks
• IV Bisphosphonate q 4 weeks
• AMG 162- 180 mg q 4 weeks

Primary outcomes

• uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 — 13 weeks
  Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.