Status:
COMPLETED
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
Lead Sponsor:
Amgen
Conditions:
Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Bone Metastases in Subjects With Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00104650
Start Date
January 1 2005
End Date
March 1 2010
Last Update
January 24 2011
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