Spots Global Cancer Trial Database for Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy
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Trial Identification
Brief Title: Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy
Official Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY
Study ID: NCT02609828
Interventions
Study Description
Brief Summary: The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.
Detailed Description: This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group Phase 3 study in cancer subjects requiring treatment with background opioids for pain due to bone metastasis. Approximately 144 subjects will be randomized to one of 2 treatment groups in a 1:1 ratio (approximately 72 subjects per group). Subjects will receive a total of 3 subcutaneous injections, separated by 8 weeks in addition to background opioids administered throughout the study. Treatment groups will include: 1. Placebo SC (matching tanezumab SC) in addition to background opioid therapy. 2. Tanezumab 20 mg SC in addition to background opioid therapy. The study consists of three periods: Pre-Treatment (up to 37 days), Double-Blind Treatment (24 weeks) and Safety Follow-up (24 weeks).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Instituto de Oncologia de Rosario, Rosario, Santa FE, Argentina
Monash Medical Centre, Clayton, Victoria, Australia
Monash Medical Centre, East Bentleigh, Victoria, Australia
Landesklinikum Krems, Krems, , Austria
Nuhr Medical Center, Senftenberg, , Austria
Associacao Hospital de Caridade de Ijui, Ijui, RIO Grande DO SUL, Brazil
INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII, Rio de Janeiro, RJ, Brazil
Fundação Pio XII-Hospital de Cancer de Barretos, Barretos, SAO Paulo, Brazil
Centro de Ensino e Pesquisa da Fundacao Amaral Carvalho, Jau, SAO Paulo, Brazil
Fundacao do ABC - Faculdade de Medicina do ABC - CEPHO, Santo Andre, SAO Paulo, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral, Itajai, SC, Brazil
Fundacao do ABC-Faculdade de Medicina do ABC, Santo Andre, SP, Brazil
Hospital AC Camargo_Fundacao Antonio Prudente, Sao Paulo, SP, Brazil
Centro de Pesquisa Clinica do IBCC - Instituto Brasileiro de Controle do Cancer, Sao Paulo, SP, Brazil
Hospital AC Camargo_Fundacao Antonio Prudente, Sao Paulo, , Brazil
James Lind Centro de lnvestigacion del Cancer, Araucania, , Chile
The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology, Hefei, Anhui, China
The Fifth Medical Center of PLA General Hospital, Beijing, Beijing, China
Daping Hospital, Research Institute of Surgery Third Military Medical University, Chongqing, Chongqing, China
Harbin Medical University Cancer Hospital/Oncology Department, Harbin, Heilongjiang, China
Henan Cancer Hospital/Respiration internal medicine, Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China
Oncology Department, West China Hospital of Sichuan University, Chengdu, Sichuan, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Tianjin Cancer Hospital, Tianjin, , China
Urocentrum Plzen Research Site s.r.o., Plzen, , Czechia
Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Centrum pro lecbu bolesti, Praha 2, , Czechia
Veszprem Megyei Tudogyogyintezet Farkasgyepu, Farkasgyepu, , Hungary
CRU Hungary Ltd., MISEK Hematology Department-CRU Co., Miskolc, , Hungary
CRU Hungary Ltd., MISEK-CRU, Miskolc, , Hungary
Josa Andras Hospital, Clinical Research Department, Nyiregyhaza, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyiregyhaza, , Hungary
Help-MR Diagnosztika Kft., Szekesfehervar, , Hungary
HaEmek Medical Center, Afula, , Israel
Rambam Health Care Campus, Haifa, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
National Hospital Organization Toyohashi Medical Center, Toyohashi, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Gunma Prefectural Cancer Center, Ota, Gunma, Japan
Nishinomiya Municipal Central Hospital, Nishinomiya, Hyogo, Japan
The Hospital of Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
Saga-Ken Medical Centre Koseikan, Saga, , Japan
National Hospital Organization Tokyo Medical Center, Tokyo, , Japan
Clinical Trial Pharmacy, National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Imaging Facilities, National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Clinical Trial Pharmacy, Severance Hospital, Seoul, , Korea, Republic of
Imaging Facilities, Severance Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Powiatowy Zespol Zakladow Opieki Zdrowotnej Oddzial Opieki Paliatywnej, Bedzin, , Poland
NZOZ Vitamed im. Edyty Jakubow, Bialystok, , Poland
Poradnia Otropedyczno-Urazowa; Gabient RTG, Bialystok, , Poland
Pracownia RTG Helimed, Czeladz, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej, Zespol Medyczno-Opiekunczy Alicja Kluczna, Dabrowa Gornicza, , Poland
Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku, Gdansk, , Poland
Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach NZOZ Hospicjum Milosierdzia Bozego, Gliwice, , Poland
Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach, NZOZ Hospicjum Milosierdzia Bozego, Gliwice, , Poland
Regionalny Szpital Specjalistyczny im. Dr. Wl.Bieganskiego, Oddzial Onkologii Klinicznej, Grudziadz, , Poland
SCANiX Sp.z o.o, Katowice, , Poland
NZOZ "Vegamed", Katowice, , Poland
Helimed Diagnostic Imaging Sp. z o.o., Sp. komandytowa, Katowice, , Poland
Helimed Diagnostic Imaging Sp. z.o.o., Sp. komandytowa, Katowice, , Poland
Centrum Diagnostyki Obrazowej EPIONE, Katowice, , Poland
NZOZ Neuromed M. i M. Nastaj Sp. P., Lublin, , Poland
SK Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu,, Poznan, , Poland
Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej w Centrum Onkologii -Instytucie, Warszawa, , Poland
Szpital LUX MED, Warszawa, , Poland
SC Oncolab SRL, Craiova, Dolj, Romania
S.C. Oncocenter Oncologie Clinica S.R.L., Timisoara, Timis, Romania
Spitalul Clinic C.F. 2 Bucuresti. Departament Oncologie, Sectia Medicala 2, Bucuresti, , Romania
Narodny onkologicky ustav, Bratislava, , Slovakia
DEMOMED s.r.o., Nove Zamky, , Slovakia
MUDr. Viliam Cibik, PhD, s.r.o., Pruske, , Slovakia
Fakultna Nemocnica S Poliklinikou Zilina, Zilina, , Slovakia
Hospital General Universitario de Elche Servicio de Farmacia, Elche, Alicante, Spain
Hospital General Universitario de Elche, Elche, Alicante, Spain
Hospital Can Misses, Ibiza, Islas Baleares, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitario de la Princesa, Madrid, , Spain
Hospital La Moraleja, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
St George's University Hospitals NHS Foundation Trust, Tooting, London, United Kingdom
NHS Lothian, Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom
NHS Lothian, Western General Hospital, Edinburgh, Scotland, United Kingdom
NHS Lothian, Edinburgh, Scotland, United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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