A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma

• Conditions: Treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or multiple myeloma; MedDRA version: 8.1Level: LLTClassification code 10027452Term: Metastases to bone

• Registration Number: EUCTR2006-000848-65-DE
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1690

Inclusion Criteria

-Adult with histologically or cytologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
-Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis (or lytic bone lesion from multiple myeloma)
-Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
-Adequate organ function as defined by the following criteria:
a) serum aspartate aminotransferase (AST) = 5 x upper limit of normal (ULN)
b) serum alanine aminotransferase (ALT) = 5 x ULN
c) serum total bilirubin = 2 x ULN
d) creatinine clearance (Cockroft-Gault, formula included in Section 6.3 of protocol) = 30 mL/min
e) albumin-adjusted serum calcium = 2.0 mmol/L (8.0 mg/dL) and = 2.9 mmol/L (11.5 mg/dL). Albumin-adjusted serum calcium, if applicable, will be calculated by the central laboratory.
-Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Diagnosis of breast or prostate cancer
-Current or prior IV bisphosphonate administration
-Current or prior oral bisphosphonate for the treatment of bone metastasis / osteolytic lesion
-Planned radiation therapy or surgery to bone
-Prior administration of denosumab
-Known brain metastases
-Life expectancy less than 6 months
-Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
-Active dental or jaw condition which requires oral surgery
-Non-healed dental/oral surgery
-Planned invasive dental procedure over the course of the study
-Evidence of any of the following conditions per subject self report or medical chart review:
a) any other prior malignancy (other than basal cell carcinoma, or in situ cervical cancer) with active disease within 3 years before randomization
b) known infection with human immunodeficiency virus
c)active infection with Hepatitis B or Hepatitis C virus
-Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
-Thirty days or less since receiving an investigational product or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical trial
-Pregnant or breast-feeding women
-Subject with reproductive potential who will not agree to use effective contraception (as defined by the principal investigator or designee)
-Known sensitivity to any of the products to be administered during the study (eg, zoledronic acid, mammalian derived products, calcium or vitamin D)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified