Double-Blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Metastases in Subjects With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00330759

Purpose

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Condition	Intervention	Phase
Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma	Drug: Zoledronic Acid Biological: Denosumab	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma Prostate Cancer

Drug Information available for: Zoledronic acid Denosumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Amgen:

Primary Outcome Measures:

Time to the first on-study SRE (non inferiority test) [ Time Frame: N/A as it is an event driven analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to the first on-study SRE (superiority test) [ Time Frame: N/A as it is an event driven analysis ] [ Designated as safety issue: No ]
Time to the first-and-subsequent on-study SRE (multiple event analysis) [ Time Frame: N/A as it is an event driven analysis ] [ Designated as safety issue: No ]
Subject incidence of treatment-emergent adverse events [ Time Frame: N/A as it is an event driven analysis ] [ Designated as safety issue: Yes ]
Changes in laboratory values [ Time Frame: N/A as it is an event driven analysis ] [ Designated as safety issue: Yes ]
Incidence of anti-Denosumab antibody(binding and neutralizing) formation [ Time Frame: N/A as it is an event driven analysis ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1690
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
845 subjects with advanced cancer and MM :zoledronic acid: Active Comparator Active Comparator IV over 15 minutes + placebo SC Q4W	Drug: Zoledronic Acid 4mg IV Zoledronic Acid over 15 minutes
845 subjects with advanced cancer and MM: denosumab: Experimental SC injection Denosumab and IV infusion of zoledronic acid placebo Q4W	Biological: Denosumab 120 mg SC Q4W

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330759

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050244
Study First Received:	May 25, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00330759
Health Authority:	Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; France: CCPPRB Central Ethics Committee; France: Ministry of Health; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Greece: National Organization for Medicines; Greece: National Organization for Medicines,; Hungary: Ministry of Health, Social and Family Affairs,; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Italy: Local Ethics Committees; Italy: Ministry of Health; Italy: Ministry of Health; Latvia: State Agency of Medicines; Latvia: State Agency of Medicines, Lithuania: Ministry of Health,; Lithuania: Ministry of Health; Lithuania: State Medicines Control Agency of Lithuania; Mexico: COFEPRIS; Mexico: Ministry of Health; Mexico: Ministry of Health, Netherlands: Medicines Evaluation Board,; Mexico: SSA (Secretaria de Salud Publica); Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Netherlands: Medicines Evaluation Board; Panama: Ministry of Health; Peru: INS (Instituto Nacional de Salud); Peru: Ministry of Health; Peru: Ministry of Health; Poland: Drug Institut; Poland: Drug Institut,; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED); Portugal: National Institute of Pharmacy and Medicines; Portugal: National Institute of Pharmacy and Medicines,; Romaina: National Medicines Agency; Romania: Ministry of Health and the Family; Romania: Ministry of Health and the Family,; Romania: Romanian National Drug Agency; Israel: Ministry of Health; Austria: Secretariat of Health, Belgium: Pharmaceutical Inspectorate,; Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Directorate-General for Medicinal Products; Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: FPS of Public Health, Food Chain Security and Environment; Belgium: Pharmaceutical Inspectorate; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement; Brazil: ANVISA (Agência Nacional de Vigilância Sanitária); Brazil: Ministry of Health; Brazil: Ministry of Health; Bulgaria: Bulgarian Drug Agency; Bulgaria: Ministry of Health; Bulgaria: Ministry of Health; Canada: Health Canada; Canada: Health Products and Food Branch; Canada: Health Products and Food Branch,; Canada: Institutional Review Board; Chile: Health Ministry; Chile: Health Ministry,; Czech Republic: State Institute for Drug Control; Czech Republic: State Institute for Drug Control; Czech Republic: Statni ustav pro kontrolu leciv; Israel: Ministry of Health; Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health); Russia: Ministry of Health; Russia: Ministry of Health,; Slovakia: Ministry of Health; Slovakia: State Institiute for Drug Control; Slovakia: Štátny ústav pre kontrolu lieciv; South Africa: Department of Health; South Africa: Department of Health, Spain: Spanish Drug Agency,; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; Sweden: Central Ethics Committee; Sweden: Lakemedelsverket; Sweden: Medical Products Agency; Switzerland: Agency for Therapeutic Products; Switzerland: Local Ethics Committee; Switzerland: Swissmedic (Swiss Agency for Therapeutic Products); Turkey: Ministry of Health, United Kingdom: Medicines and Healthcare Products Regulatory Agency,; Ukraine: Ministry of Health; Ukraine: Ministry of Health; Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre); United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Food and Drug Administration; United States: Institutional Review Board; United States: IntegReview Ethical Review Board; United States: Quorom Institutional Review Board; United States: Western Institutional Review Board; Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica); Argentina: Ministry of Health; Argentina: Ministry of Health, Australia: Therapeutic Goods Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: Therapeutic Goods Administration; Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information; Austria: Bundesamt fur Sicherheit im Gesundheitswesen; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Austria: Central Ethics Committee; Austria: Competant Authority; Austria: Federal Ministry for Health and Women; Austria: Secretariat of Health; Slovakia: Ministry of Health,

Keywords provided by Amgen:

Bone metastases
lytic bone lesions
advanced cancer
multiple myeloma
lymphoma
solid tumors

skeletal fractures
spinal cord compressions, radiation to bone
surgery to bone, bisphosphonates
denosumab
skeletal related events

Study placed in the following topic categories:

Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Blood Protein Disorders
Bone neoplasms
Fractures, Bone
Paraproteinemias
Urogenital Neoplasms
Hemostatic Disorders
Bone Diseases
Hemorrhagic Disorders
Musculoskeletal Diseases
Multiple myeloma
Spinal Cord Compression

Neoplasm Metastasis
Lymphoma
Zoledronic acid
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Genital Diseases, Male
Multiple Myeloma
Diphosphonates
Bone Marrow Diseases
Lymphoproliferative Disorders
Prostatic Neoplasms
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Neoplasms by Site
Pathologic Processes
Neoplasms by Histologic Type

Immune System Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009