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

NCT02609828 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: A40910612013-002223-42CANCER PAIN PH 3 SC STUDY
• Study Type: interventional
• Target: 156
• Locations: 15 countries
• Sites: 87

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.

Conditions

Bone Metastasis; Cancer Pain

Keywords

Metastatic cancer bone pain; Multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8

  Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8.

  Baseline, Week 8

Secondary Outcomes (24)

• Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24

  Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24

• Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24

  Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24

• Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24

  Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24

• Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24

  Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24

• Change From Baseline in the Daily Average Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24

  Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24

Study Arms (2)

Arm 1

EXPERIMENTAL

Tanezumab 20 mg subcutaneously

Drug: Tanezumab

Arm 2

PLACEBO COMPARATOR

Placebo matched to active treatment subcutaneously

Drug: Tanezumab

Interventions

Tanezumab DRUG

Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.

Also known as: PF-04383119

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Personally signed and dated informed consent document.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Male or female, ≥18 years of age
• Weight ≥40 kg at Screening
• Cancer diagnosed as having metastasized to bone or multiple myeloma.
• Imaging confirmation of bone metastasis at Screening or within 120 days prior to the Screening visit.
• Expected to require daily opioid medication throughout the course of the study.
• Willing to not use prohibited medications (including NSAIDs) throughout the duration of the study.
• Average Pain Score ≥5 at Screening for the index bone metastasis cancer pain site.
• Patient's Global Assessment of Cancer Pain of "fair", "poor" or "very poor" at Screening.
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 at Screening.
• Adequate bone marrow, renal and liver function at Screening.
• International Normalized Ratio (INR) or prothrombin time (PT) \<1.5 x ULN at Screening unless being treated with anticoagulant medication.
• Females must either be not of childbearing potential or, if of childbearing potential and at risk for pregnancy, must be willing to use at least one highly effective method of contraception throughout the study and for 112 days (16 weeks) after the last dose of assigned subcutaneous study medication.

You may not qualify if:

• Pain related to an oncologic emergency.
• Brain metastasis or leptomeningeal metastasis.
• Presence of hypercalcemia at Screening.
• Pain primarily classified as not predominantly related to a bone metastasis.
• Systemic treatment for the primary malignancy or bone metastasis started within 30 days of the Baseline Assessment Period.
• Chemotherapies associated with peripheral neuropathy (ie, paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide or bortezomib) are prohibited during the study from 30 days prior to the first day of the Baseline Assessment Period to Week 48.
• Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 30 days of the Baseline Assessment Period.
• Concurrent adjuvant analgesics unless started at least 30 days prior to the start of the Baseline Assessment Period and maintained at a stable dose.
• Diagnosis of osteoarthritis of the knee or hip or findings consistent with osteoarthritis in the shoulder.
• History of significant trauma or surgery to a major joint within one year prior to Screening.
• History of osteonecrosis or osteoporotic fracture.
• X-ray evidence at Screening of: 1) rapidly progressive osteoarthritis, 2) atrophic or hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture.
• Signs and symptoms of clinically significant cardiac disease.
• Evidence of orthostatic hypotension at Screening or at Baseline prior to randomization.
• Diagnosis of a transient ischemic attack in the 6 months prior to Screening or diagnosis of stroke with significant residual deficits.

Sponsors & Collaborators

• Pfizer: lead
• Eli Lilly and Company: collaborator

Study Sites (89)

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Monash Medical Centre

East Bentleigh, Victoria, 3165, Australia

Location

Landesklinikum Krems

Krems, 3500, Austria

Location

Nuhr Medical Center

Senftenberg, 3541, Austria

Location

INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

Associacao Hospital de Caridade de Ijui

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, 88.301-220, Brazil

Location

Fundação Pio XII-Hospital de Cancer de Barretos

Barretos, São Paulo, 14.784-400, Brazil

Location

Centro de Ensino e Pesquisa da Fundacao Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

Location

Fundacao do ABC - Faculdade de Medicina do ABC - CEPHO

Santo André, São Paulo, 09060-650, Brazil

Location

Fundacao do ABC-Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-870, Brazil

Location

Hospital AC Camargo_Fundacao Antonio Prudente

São Paulo, São Paulo, 01509-900, Brazil

Location

Centro de Pesquisa Clinica do IBCC - Instituto Brasileiro de Controle do Cancer

São Paulo, São Paulo, 03102-006, Brazil

Location

Hospital AC Camargo_Fundacao Antonio Prudente

São Paulo, 01509-900, Brazil

Location

James Lind Centro de lnvestigacion del Cancer

Araucania, 4800827, Chile

Location

The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology

Hefei, Anhui, 230022, China

Location

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

Daping Hospital, Research Institute of Surgery Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Harbin Medical University Cancer Hospital/Oncology Department

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital/Respiration internal medicine

Zhengzhou, Henan, 450008, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

Wuhan, Hubei, 430030, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Oncology Department, West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Urocentrum Plzen Research Site s.r.o.

Pilsen, 30100, Czechia

Location

Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Centrum pro lecbu bolesti

Prague, 128 00, Czechia

Location

Veszprem Megyei Tudogyogyintezet Farkasgyepu

Farkasgyepű, 8582, Hungary

Location

CRU Hungary Ltd., MISEK Hematology Department-CRU Co.

Miskolc, 3529, Hungary

Location

CRU Hungary Ltd., MISEK-CRU

Miskolc, 3529, Hungary

Location

Josa Andras Hospital, Clinical Research Department

Nyíregyháza, 4400, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Help-MR Diagnosztika Kft.

Székesfehérvár, 8000, Hungary

Location

HaEmek Medical Center

Afula, 1834111, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

National Hospital Organization Toyohashi Medical Center

Toyohashi, Aichi-ken, 440-8510, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Gunma Prefectural Cancer Center

Ōta, Gunma, 373-8550, Japan

Location

Nishinomiya Municipal Central Hospital

Nishinomiya, Hyōgo, 663-8014, Japan

Location

The Hospital of Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Saga-Ken Medical Centre Koseikan

Saga, 840-8571, Japan

Location

National Hospital Organization Tokyo Medical Center

Tokyo, 152-8902, Japan

Location

Powiatowy Zespol Zakladow Opieki Zdrowotnej Oddzial Opieki Paliatywnej

Będzin, 42-500, Poland

Location

NZOZ Vitamed im. Edyty Jakubow

Bialystok, 15-215, Poland

Location

Poradnia Otropedyczno-Urazowa; Gabient RTG

Bialystok, 15-437, Poland

Location

Pracownia RTG Helimed

Czeladź, 41-250, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej, Zespol Medyczno-Opiekunczy Alicja Kluczna

Dąbrowa Górnicza, 41-300, Poland

Location

Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku

Gdansk, 80-208, Poland

Location

Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach NZOZ Hospicjum Milosierdzia Bozego

Gliwice, 44-100, Poland

Location

Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach, NZOZ Hospicjum Milosierdzia Bozego

Gliwice, 44-100, Poland

Location

Regionalny Szpital Specjalistyczny im. Dr. Wl.Bieganskiego, Oddzial Onkologii Klinicznej

Grudziądz, 86-300, Poland

Location

SCANiX Sp.z o.o

Katowice, 40-057, Poland

Location

NZOZ "Vegamed"

Katowice, 40-060, Poland

Location

Helimed Diagnostic Imaging Sp. z o.o., Sp. komandytowa

Katowice, 40-760, Poland

Location

Helimed Diagnostic Imaging Sp. z.o.o., Sp. komandytowa

Katowice, 40-760, Poland

Location

Centrum Diagnostyki Obrazowej EPIONE

Katowice, 40-872, Poland

Location

NZOZ Neuromed M. i M. Nastaj Sp. P.

Lublin, 20-064, Poland

Location

SK Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu,

Poznan, 61-245, Poland

Location

Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej w Centrum Onkologii -Instytucie

Warsaw, 02-781, Poland

Location

Szpital LUX MED

Warsaw, 02-801, Poland

Location

SC Oncolab SRL

Craiova, Dolj, 200385, Romania

Location

S.C. Oncocenter Oncologie Clinica S.R.L.

Timișoara, Timiș County, 300166, Romania

Location

Spitalul Clinic C.F. 2 Bucuresti. Departament Oncologie, Sectia Medicala 2

Bucharest, 011464, Romania

Location

Narodny onkologicky ustav

Bratislava, 833 10, Slovakia

Location

DEMOMED s.r.o.

Nové Zámky, 94001, Slovakia

Location

MUDr. Viliam Cibik, PhD, s.r.o.

Pruské, 018 52, Slovakia

Location

Fakultna Nemocnica S Poliklinikou Zilina

Žilina, 012 07, Slovakia

Location

Clinical Trial Pharmacy, National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Imaging Facilities, National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Clinical Trial Pharmacy, Severance Hospital

Seoul, 03722, South Korea

Location

Imaging Facilities, Severance Hospital

Seoul, 03722, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital General Universitario de Elche Servicio de Farmacia

Elche, Alicante, 03203, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Can Misses

Ibiza Town, Balearic Islands, 07800, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital La Moraleja

Madrid, 28050, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

St George's University Hospitals NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

Location

NHS Lothian, Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

NHS Lothian, Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

NHS Lothian

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (1)

• Fallon M, Sopata M, Dragon E, Brown MT, Viktrup L, West CR, Bao W, Agyemang A. A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis. Oncologist. 2023 Dec 11;28(12):e1268-e1278. doi: 10.1093/oncolo/oyad188.

  PMID: 37343145 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Cancer Pain; Multiple Myeloma

Interventions

tanezumab

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 20, 2015
• Study Start: October 28, 2015
• Primary Completion: September 17, 2020
• Study Completion: June 25, 2021
• Last Updated: February 16, 2023
• Results First Posted: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); CN (11); AR (1); BR (10); CZ (2); HU (6); AU (2); SL (4); ES (7); CL (1); PL (18); IL (3); JP (7); RO (3); KR (8)