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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 Site Alabaster, Alabama  
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Lewes, Delaware  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Boise, Idaho  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Bangor, Maine  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Branson, Missouri  
Research Site Las Vegas, Nevada  
Research Site Hooksett, New Hampshire  
Research Site Belleville, New Jersey  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Clarksburg, West Virginia