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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Amgen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00330759
First received: May 25, 2006
Last updated: November 24, 2010
Last verified: November 2010
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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 |
Biological: Denosumab Drug: Zoledronic Acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| 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. |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to the first on-study SRE (non inferiority test) [ Time Frame: until approximately 745 subjects have experienced at least one on-study SRE (anticipated to be approximately 34 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to the first on-study SRE (superiority test) [ Time Frame: until approximately 745 subjects have experienced at least one on-study SRE (anticipated to be approximately 34 months) ] [ Designated as safety issue: No ]
- Time to the first-and-subsequent on-study SRE (multiple event analysis) [ Time Frame: until approximately 745 subjects have experienced at least one on-study SRE (anticipated to be approximately 34 months) ] [ Designated as safety issue: No ]
- Subject incidence of treatment-emergent adverse events [ Time Frame: until approximately 745 subjects have experienced at least one on-study SRE (anticipated to be approximately 34 months) ] [ Designated as safety issue: Yes ]
- Incidence of anti-Denosumab antibody (binding and neutralizing) formation [ Time Frame: until approximately 745 subjects have experienced at least one on-study SRE (anticipated to be approximately 34 months) ] [ Designated as safety issue: Yes ]
- Changes in serum chemistry and hematology values and toxicity grade shifts from baseline to "worst" on study values [ Time Frame: until approximately 745 subjects have experienced at least one on-study SRE (anticipated to be approximately 34 months) ] [ Designated as safety issue: Yes ]
| Enrollment: | 1779 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | October 2011 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: zoledronic acid
denosumab placebo with active zoledronic acid
|
Drug: Zoledronic Acid
4mg IV Zoledronic Acid over minimum 15 minutes Q4W
Other Name: Zometa
|
|
Experimental: denosumab
active denosumab with zoledronic acid placebo
|
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
Show 330 Study Locations
Show 330 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00330759 History of Changes |
| Other Study ID Numbers: | 20050244 |
| Study First Received: | May 25, 2006 |
| Last Updated: | November 24, 2010 |
| Health Authority: | 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 Romaina: National Medicines Agency Romania: Ministry of Health and the Family Romania: Ministry of Health and the Family, Romania: Romanian National Drug Agency 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: 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: 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: Institutional Review Board United States: IntegReview Ethical Review Board United States: Quorom Institutional Review Board United States: Western Institutional Review Board Mexico: Ministry of Health, Netherlands: Medicines Evaluation Board, Austria: Bundesamt für Sicherheit im Gesundheitswesen Austria: Central Ethics Committee Austria: Competant Authority Austria: Federal Ministry for Health and Women Austria: Secretariat 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 Bulgaria: Bulgarian Drug Agency 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: Statni ustav pro kontrolu leciv European Union: European Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: CCPPRB Central Ethics Committee France: Ministry of Health 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 Israel: Ministry of Health Italy: Local Ethics Committees 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: SSA (Secretaria de Salud Publica) Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research Netherlands: Medicines Evaluation Board Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider Panama: Ministry of Health Peru: INS (Instituto Nacional de Salud) 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, |
Keywords provided by Amgen:
|
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 |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Bone Diseases Musculoskeletal Diseases Zoledronic acid Diphosphonates |
ClinicalTrials.gov processed this record on May 16, 2013