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

January 25, 2023 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Santa FE
      • Rosario, Santa FE, Argentina, S2000KZE
        • Instituto de Oncología de Rosario
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • East Bentleigh, Victoria, Australia, 3165
        • Monash Medical Centre
      • Krems, Austria, 3500
        • Landesklinikum Krems
      • Senftenberg, Austria, 3541
        • Nuhr Medical Center
      • Sao Paulo, Brazil, 01509-900
        • Hospital AC Camargo_Fundacao Antonio Prudente
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Associacao Hospital de Caridade de Ijui
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII
    • SAO Paulo
      • Barretos, SAO Paulo, Brazil, 14.784-400
        • Fundacao Pio XII-Hospital de Cancer de Barretos
      • Jau, SAO Paulo, Brazil, 17210-120
        • Centro de Ensino e Pesquisa da Fundacao Amaral Carvalho
      • Santo Andre, SAO Paulo, Brazil, 09060-650
        • Fundacao do ABC - Faculdade de Medicina do ABC - CEPHO
    • SC
      • Itajai, SC, Brazil, 88.301-220
        • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
    • SP
      • Santo Andre, SP, Brazil, 09060-870
        • Fundacao do ABC-Faculdade de Medicina do ABC
      • Sao Paulo, SP, Brazil, 01509-900
        • Hospital AC Camargo_Fundacao Antonio Prudente
      • Sao Paulo, SP, Brazil, 03102-006
        • Centro de Pesquisa Clinica do IBCC - Instituto Brasileiro de Controle do Cancer
      • Araucania, Chile, 4800827
        • James Lind Centro de lnvestigacion del Cancer
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
    • Beijing
      • Beijing, Beijing, China, 100071
        • The Fifth Medical Center of PLA General Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Daping Hospital, Research Institute of Surgery Third Military Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital/Oncology Department
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital/Respiration internal medicine
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Shanghai Sixth People's Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Oncology Department, West China Hospital of Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Plzen, Czechia, 30100
        • Urocentrum Plzen Research Site s.r.o.
      • Praha 2, Czechia, 128 00
        • Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Centrum pro lecbu bolesti
      • Farkasgyepu, Hungary, 8582
        • Veszprem Megyei Tudogyogyintezet Farkasgyepu
      • Miskolc, Hungary, 3529
        • CRU Hungary Ltd., MISEK Hematology Department-CRU Co.
      • Miskolc, Hungary, 3529
        • CRU Hungary Ltd., MISEK-CRU
      • Nyiregyhaza, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Hospital, Clinical Research Department
      • Szekesfehervar, Hungary, 8000
        • Help-MR Diagnosztika Kft.
      • Afula, Israel, 1834111
        • Haemek Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Ramat Gan, Israel, 52621
        • Chaim Sheba Medical Center
      • Saga, Japan, 840-8571
        • Saga-ken Medical Centre Koseikan
      • Tokyo, Japan, 152-8902
        • National Hospital Organization Tokyo Medical Center
    • Aichi
      • Toyohashi, Aichi, Japan, 440-8510
        • National Hospital Organization Toyohashi Medical Center
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Gunma
      • Ota, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • The Hospital of Hyogo College of Medicine
      • Nishinomiya, Hyogo, Japan, 663-8014
        • Nishinomiya Municipal Central Hospital
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Clinical Trial Pharmacy, Severance Hospital
      • Seoul, Korea, Republic of, 03722
        • Imaging Facilities, Severance Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Clinical Trial Pharmacy, National Cancer Center
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Imaging Facilities, National Cancer Center
      • Bedzin, Poland, 42-500
        • Powiatowy Zespol Zakladow Opieki Zdrowotnej Oddzial Opieki Paliatywnej
      • Bialystok, Poland, 15-215
        • NZOZ Vitamed im. Edyty Jakubow
      • Bialystok, Poland, 15-437
        • Poradnia Otropedyczno-Urazowa; Gabient RTG
      • Czeladz, Poland, 41-250
        • Pracownia RTG Helimed
      • Dabrowa Gornicza, Poland, 41-300
        • Niepubliczny Zaklad Opieki Zdrowotnej, Zespol Medyczno-Opiekunczy Alicja Kluczna
      • Gdansk, Poland, 80-208
        • Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku
      • Gliwice, Poland, 44-100
        • Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach NZOZ Hospicjum Milosierdzia Bozego
      • Gliwice, Poland, 44-100
        • Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach, NZOZ Hospicjum Milosierdzia Bozego
      • Grudziadz, Poland, 86-300
        • Regionalny Szpital Specjalistyczny im. Dr. Wl.Bieganskiego, Oddzial Onkologii Klinicznej
      • Katowice, Poland, 40-057
        • SCANiX Sp.z o.o
      • Katowice, Poland, 40-060
        • NZOZ "Vegamed"
      • Katowice, Poland, 40-760
        • Helimed Diagnostic Imaging Sp. z o.o., Sp. komandytowa
      • Katowice, Poland, 40-760
        • Helimed Diagnostic Imaging Sp. z.o.o., Sp. komandytowa
      • Katowice, Poland, 40-872
        • Centrum Diagnostyki Obrazowej EPIONE
      • Lublin, Poland, 20-064
        • NZOZ Neuromed M. i M. Nastaj Sp. P.
      • Poznan, Poland, 61-245
        • SK Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu,
      • Warszawa, Poland, 02-801
        • Szpital LUX MED
      • Warszawa, Poland, 02-781
        • Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej w Centrum Onkologii -Instytucie
      • Bucuresti, Romania, 011464
        • Spitalul Clinic C.F. 2 Bucuresti. Departament Oncologie, Sectia Medicala 2
    • Dolj
      • Craiova, Dolj, Romania, 200385
        • Sc Oncolab Srl
    • Timis
      • Timisoara, Timis, Romania, 300166
        • S.C. ONCOCENTER Oncologie Clinica S.R.L.
      • Bratislava, Slovakia, 833 10
        • Narodny onkologicky ustav
      • Nove Zamky, Slovakia, 94001
        • DEMOMED s.r.o.
      • Pruske, Slovakia, 018 52
        • MUDr. Viliam Cibik, PhD, s.r.o.
      • Zilina, Slovakia, 012 07
        • Fakultna nemocnica s poliklinikou Zilina
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Madrid, Spain, 28050
        • Hospital La Moraleja
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche Servicio de Farmacia
    • Islas Baleares
      • Ibiza, Islas Baleares, Spain, 07800
        • Hospital Can Misses
    • London
      • Tooting, London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SA
        • NHS Lothian, Royal Infirmary of Edinburgh
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • NHS Lothian, Western General Hospital
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • NHS Lothian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • History, diagnosis, or signs and symptoms of clinically significant neurological disease.
  • Total impact score of >7 on the Survey of Autonomic Symptoms (SAS) at Screening.
  • Past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening.
  • History of significant alcohol, analgesic, or narcotic substance abuse within the six months prior to Screening.
  • Planned surgical procedure during the duration of the study.
  • Considered unfit for surgery or not willing to undergo joint replacement surgery if required.
  • Known hypersensitivity to opioids or an underlying medical condition contraindicating opioid use.
  • History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
  • Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor antibody.
  • Presence of drugs of abuse, prescription medications without a valid prescription or other illegal drugs at Screening.
  • Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests at Screening indicative of current infection.
  • Investigational site staff members and their family members, or Pfizer employees directly involved in the conduct of the trial.
  • Participation in other studies involving investigational drug(s) within 30 days (or 90 days for investigational biologics) before Baseline Assessment Period and/or during study participation.
  • Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use one (1) highly effective method of contraception throughout the study and for 112 days after last dose of investigational product.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Tanezumab 20 mg subcutaneously
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Other Names:
  • PF-04383119
Placebo Comparator: Arm 2
Placebo matched to active treatment subcutaneously
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Other Names:
  • PF-04383119

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8
Time Frame: Baseline, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24
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 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 Weeks 1, 2, 4, 6, 12, 16 and 24 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 each specified week.
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
Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily worst pain intensity in the index bone metastasis cancer pain site is assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. The participants describe their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily worst pain intensity was mean of daily worst pain intensity NRS score during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 daily worst pain intensity value was the mean of the daily worst pain intensity NRS scores recorded for each of the 7 days prior to the each specified week.
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
Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Weekly average pain intensity in the non-index 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. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants described their weekly pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly average pain intensity was weekly average pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly average pain intensity value was the weekly average pain intensity NRS scores recorded on any day from the span of 7 days prior to specified week.
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
Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Weekly worst pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants describe their weekly worst pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly worst pain intensity was weekly worst pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly worst pain intensity value was the weekly worst pain intensity NRS scores which was recorded on any day from the span of 7 days prior to specified week.
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
Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily average pain intensity in the non-index visceral 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 described their pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline is defined as the mean average daily pain intensity NRS score during the baseline assessment period prior to randomization. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily average pain intensity scores for the 7 days prior to the each specified week.
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily worst 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 worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week.
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
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 = 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 IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily average pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of >= 30, 50, 70, and 90 % in daily average pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in 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
Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily worst 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 = more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of >= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24
Time Frame: Baseline, Weeks 2, 4, 8, 16 and 24
Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition.
Baseline, Weeks 2, 4, 8, 16 and 24
Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24
Time Frame: Baseline, Weeks 2, 4, 8, 16 and 24
Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores:1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition.
Baseline, Weeks 2, 4, 8, 16 and 24
Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Time Frame: Weeks 1, 2, 4, 6, 8, 12, 16 and 24
In this outcome measure average daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED).
Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Time Frame: Weeks 1, 2, 4, 6, 8, 12, 16 and 24
In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported.
Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24
Time Frame: Baseline, Weeks 2, 4, 8, 16, and 24
OR-SDS: questionnaire evaluated opioid-related 12 symptoms. For each symptom, participants assigned integer scores to assess severity (none =0 to very severe =4), distress (none =0 to very much =5), and frequency (none =0 to almost constantly =4; participants reported number of retching/vomiting episodes (none =0, 1-2 episodes =1, 3-4 episodes =2, 5-6 episodes =3, >6 episodes =4). Frequency composite score: mean of frequency scores from all symptoms, ranged from 0 (none) to 4 (almost constantly); higher scores = worse condition. Severity composite score: mean of severity scores from all 12 symptoms, ranged from 0 (none) to 4 (maximum severity); higher scores = worse condition. Distress composite score: mean of distress scores from all 12 symptoms, ranged from 0 (none) to 5 (maximum distress); higher scores = worse condition. Multi domain average (MDA): average of each symptom for frequency, severity, and distress; ranged from 0 (none) to 4.34 (worse); higher scores = worse condition.
Baseline, Weeks 2, 4, 8, 16, and 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks post last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. Participants were followed up to 24 weeks after study drug last dose.
Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
Number of Participants With Laboratory Abnormalities (Normal Baseline)
Time Frame: Baseline (Day 1, before dosing) up to Week 48
Laboratory abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes < 0.8*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; leukocytes<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; total bilirubin>1.5*ULN; activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio >1.1*ULN; bilirubin >1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein; albumin<0.8*LLN, >1.2*ULN; urea nitrogen, creatinine, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; Urine: glucose, ketones, protein, HGB, bilirubin, nitrite >=1.
Baseline (Day 1, before dosing) up to Week 48
Number of Participants With Laboratory Abnormalities (Abnormal Baseline)
Time Frame: Baseline (Day 1, before dosing) up to Week 48
Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes < 0.8* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; leukocytes <0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; activated partial thromboplastin time, prothrombin time >1.1*ULN; bilirubin>1.5*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein; albumin<0.8*LLN, >1.2*ULN; urea nitrogen, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN.
Baseline (Day 1, before dosing) up to Week 48
Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period
Time Frame: Baseline (Day 1, before dosing) up to Week 24
Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change <=-40, change >-40 to -30, change >-30 to -20, change >-20 to -10, change >-10 to 0, change >0 to <10, change >=10 to <20, change >=20 to <30, change >=30 to <40 and change >=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change <=-30, change >-30 to -20, change >-20 to -10, change >-10 to 0, change >0 to <10, change >=10 to <20, change >=20 to <30 and change >=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below.
Baseline (Day 1, before dosing) up to Week 24
Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data
Time Frame: Baseline (Day 1, before dosing) up to Week 24
Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450<=Value<480 millisecond (msec), 480<=Value<500 msec and Value>=500 msec.
Baseline (Day 1, before dosing) up to Week 24
Number of Participants With Confirmed Orthostatic Hypotension
Time Frame: Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP >=20 mmHg or reduction in diastolic BP >=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (>) 150 mmHg (mean supine): reduction in systolic BP >=30 mmHg or reduction in diastolic BP >=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48
Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE
Time Frame: Day 1 of dosing up to maximum of Week 48
The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure.
Day 1 of dosing up to maximum of Week 48
Number of Participants With Abnormal Physical Examination at Screening
Time Frame: Screening (up to 37 days prior to Day 1)
Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations.
Screening (up to 37 days prior to Day 1)
Number of Participants With Individual Adjudicated Joint Safety Outcome/Event
Time Frame: During the study, maximum up to Week 48
Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome.
During the study, maximum up to Week 48
Number of Participants With At Least 1 Total Joint Replacements (TJR)
Time Frame: During the study, maximum up to Week 48
Number of participants with joint replacement surgery were reported.
During the study, maximum up to Week 48
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb)
Time Frame: Baseline (Day 1, before dosing) up to Week 48
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported.
Baseline (Day 1, before dosing) up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2015

Primary Completion (Actual)

September 17, 2020

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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