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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Bone Metastases

Thank you

Trial Information

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.


Inclusion Criteria:



- Adults with histologically/cystologically confirmed advanced cancers including solid
tumors, multiple myeloma, and lymphoma

- Radiographic evidence of at least one bone metastasis (or lytic bone lesion from
multiple myeloma); ECOG PS 0, 1, or 2

- Adequate organ function

Exclusion Criteria:

- Diagnosis of breast or prostate cancer

- Current or prior IV bisphosphonate administration

- Current or prior oral bisphosphonates for bone mets, life expectancy of less than 6
months

- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Time to the first on-study SRE (non inferiority test)

Outcome Time Frame:

until approximately 745 subjects have experienced at least one on-study SRE (anticipated to be approximately 34 months)

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)

Study ID:

20050244

NCT ID:

NCT00330759

Start Date:

June 2006

Completion Date:

October 2011

Related Keywords:

  • Bone Metastases
  • Bone metastases
  • lytic bone lesions
  • advanced cancer
  • multiple myeloma
  • lymphoma
  • denosumab
  • solid tumors
  • skeletal related events
  • skeletal fractures
  • spinal cord compressions, radiation to bone
  • surgery to bone, bisphosphonates
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Research SiteAlabaster, Alabama  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteLewes, Delaware  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteLas Vegas, Nevada  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteClarksburg, West Virginia