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Клинические исследования в Украине

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Исследования / № 00321464

Описание
Краткое названиеA Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
Полное названиеA Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa?®) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer
СпонсорAmgen
Industry
ИсточникAmgen
Под контролемArgentina: Ministry of Health, Australia: Therapeutic Goods Administration
South Africa: Department of Health
South Africa: Department of Health, Spain: Spanish Drug Agency, Sweden: Medical Products Agency, Switzerland: Agency for Therapeutic Products
Spain: Agencia Espa?±ola de Medicamentos y Productos Sanitarios
Spain: Spanish Agency of Medicines
Spain: Spanish Drug Agency
Sweden: Central Ethics Committee
Sweden: Medical Products Agency
Switzerland: Agency for Therapeutic Products
Switzerland: Local Ethics Committee
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
Turkey: 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
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Therapeutic Goods Administration
Austria: Secretariat of Health, Belgium: Pharmaceutical Inspectorate Brazil: Ministry of Health
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 F?©d?©ral Sant?© Publique, S?©curit?© de la Cha?®ne alimentaire et Environnement
Brazil: ANVISA (Ag??ncia Nacional de Vigil??ncia Sanit??ria)
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Health Canada
Canada: Health Products and Food Branch
Canada: Institutional Review Board
Chile: Health Ministry
Czech Republic: State Institute for Drug Control
Denmark: Ministry of Health
Estonia: State Agency of Medicines, France: Ministry of Health
EU: CHMP
European Union: European Medicines Agency
Finland: L?¤?¤kelaitos
France and Sweden: European Medicines Agency
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
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Evaluation Center
Latvia: State Agency of Medicines, Mexico: Ministry of Health
Lithuania: Ministry of Health
Mexico: COFEPRIS
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: Ministry of Health
Poland: Drug Institut
Romaina: National Medicines Agency
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
Slovakia: Ministry of Health
Slovakia: State Institiute for Drug Control
Краткое описаниеThe purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in
the treatment of bone metastases in subjects with advanced breast cancer.
СостояниеАктивный, набор окончен
Дата началаApril 2006
ФазаPhase 3
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Набор0
КритерииInclusion Criteria:

- Adults with histologically or cytologically confirmed breast adenocarcinoma

- radiographic evidence of at least one bone mets

- Easter Cooperative Oncology Group status of 0, 1 or 2;

- adequate organ function

Exclusion Criteria:

- Current or prior IV bisphosphonate administration

- current or prior oral bisphosphonates for bone mets

- life expectancy of less than 6 months
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеBone Metastases in Subjects With Advanced Breast Cancer
Применяемое лечение
BiologicalDenosumab
DrugZoledronic Acid
Контакты и расположение
Kharkiv Research Site
Kherson Research Site
Kiev Research Site
Lugansk Research Site
Lviv Research Site
Uzhgorod Research Site
Zaporizhzya Research Site
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