Last updated on October 2017

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.


Brief description of study

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 Study 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 170 subjects will be randomized to one of 2 treatment groups in a 1:1 ratio (approximately 85 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).

Clinical Study Identifier: NCT02609828

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Instituto de Oncologia de Rosario
Rosario, Argentina
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Fundacion Favaloro para la Docencia e Investigacion Medica
Caba, Argentina
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Monash Medical Centre
Clayton, Australia
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Monash Medical Centre
East Bentleigh, Australia
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Landesklinikum Krems
Krems, Austria
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Nuhr Medical Center
Senftenberg, Austria
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Wilhelminenspital der Stadt Wien
Wien, Austria
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INCA-Instituto Nacional de Cancer Jose Alencar Gomes da Silva/Hospital do Cancer HCIII
Rio de Janeiro, Brazil
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Hospital Sao Lucas Da Pucrs
Porto Alegre, Brazil
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Funda o Pio XII-Hospital de Cancer de Barretos
Barretos, Brazil
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Centro de Ensino e Pesquisa da Fundacao Amaral Carvalho
Jau, Brazil
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Fundacao do ABC - Faculdade de Medicina do ABC - CEPHO
Santo Andre, Brazil
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Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
Itajai, Brazil
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Fundacao do ABC- Faculdade de Medicina do ABC - CEPHO
Santo Andre, Brazil
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Instituto do Cancer do Estado de Sao Paulo "Octavio Frias de Oliveira" -ICESP
Sao Paulo, Brazil
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