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

Last updated date
Study Location
Centro de Investigación Clínica WM (CIC WM) - WM Consultorios Médicos S.A.
Caba, , C1440BBR, Argentina
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm Metastasis, Musculoskeletal Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Neoplasm Metastasis, Musculoskeletal PainPhase 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
  1. Caba,
  2. Rosario, Santa FE
  3. Krems,
  4. Ijui, RIO Grande DO SUL
  5. Rio de Janeiro, RJ
  6. Barretos, SAO Paulo
  7. Jau, SAO Paulo
  8. Itajai, SC
  9. Sao Paulo, SP
  10. Sao Paulo,
  11. Temuco, Region DE LA Araucania
  12. Temuco, Region DE LA Araucania
  13. Hefei, Anhui
  14. Beijing, Beijing
  15. Chongqing, Chongqing
  16. Harbin, Heilongjiang
  17. Zhengzhou, Henan
  18. Wuhan, Hubei
  19. Wuhan, Hubei
  20. Shanghai, Shanghai
  21. Chengdu, Sichuan
  22. Hangzhou, Zhejiang
  23. Tianjin,
  24. Praha 2, Czech Republic
  25. Plzen - Bory,
  26. Plzen,
  27. Plzen,
  28. Plzen,
  29. Praha 2,
  30. Praha 2,
  31. Muenster, North Rhine-westphalia
  32. Leipzig,
  33. Miskolc,
  34. Miskolc,
  35. Afula,
  36. Toyohashi, Aichi
  37. Kashiwa, Chiba
  38. Ota, Gunma
  39. Nishinomiya, Hyogo
  40. Nishinomiya, Hyogo
  41. Saga,
  42. Tokyo,
  43. Daegu,
  44. Daegu,
  45. Daegu,
  46. Seoul,
  47. Seoul,
  48. Seoul,
  49. Seoul,
  50. Czeladz, Silesia
  51. Bialystok,
  52. Dabrowa Gornicza,
  53. Gdansk,
  54. Gliwice,
  55. Gliwice,
  56. Grudziadz,
  57. Katowice,
  58. Katowice,
  59. Katowice,
  60. Katowice,
  61. Katowice,
  62. Lublin,
  63. Polska,
  64. Poznan,
  65. Poznan,
  66. Warszawa,
  67. Warszawa,
  68. Craiova, Dolj
  69. Timisoara, Timis
  70. Timisoara, Timis
  71. Bucuresti,
  72. Bratislava,
  73. Nove Zamky,
  74. Nove Zamky,
  75. Pruske,
  76. Zilina,
  77. Elche, Alicante
  78. Elche, Alicante
  79. Alicante,
  80. Alicante,
  81. Madrid,
  82. Madrid,
  83. Madrid,
  84. Tooting, London
  85. Edinburgh, Scotland
  86. Edinburgh, Scotland
  87. Edinburgh, Scotland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasm Metastasis
  • Musculoskeletal Pain
Intervention  ICMJE Drug: Tanezumab
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Other Name: PF-04383119
Study Arms  ICMJE
  • Experimental: Arm 1
    Tanezumab 20 mg subcutaneously
    Intervention: Drug: Tanezumab
  • Placebo Comparator: Arm 2
    Placebo matched to active treatment subcutaneously
    Intervention: Drug: Tanezumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2018)
155
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2015)
255
Estimated Study Completion Date  ICMJE May 18, 2021
Estimated Primary Completion Date August 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Chile,   China,   Czechia,   Germany,   Hungary,   Israel,   Japan,   Korea, Republic of,   Poland,   Romania,   Slovakia,   Spain,   United Kingdom
Removed Location Countries Czech Republic,   France
 
Administrative Information
NCT Number  ICMJE NCT02609828
Other Study ID Numbers  ICMJE A4091061
2013-002223-42 ( EudraCT Number )
CANCER PAIN PH 3 SC STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Principal Investigator:Christos Karapetis, MDFlinders cancer innovation centre, Flinders Medical Centre
Principal Investigator:Patricia Milhomem, MDCentro de Pesquisas Clinicas da Fundação Hospital Amaral Carvalho
Principal Investigator:Fernanda Damian, MDUnião Brasileira de Educação e Assintência Hospital Sao Lucas DA PUCRS
Principal Investigator:Rudolf Likar, MDDep. of Anesthesiology and Intensiv Care Medicine, Klinikum Klagenfurt
Principal Investigator:Ludmila Koch, MDHospital Israelita Albert Einstein
Principal Investigator:Felipe Cruz, MDIBCC - Instituto Brasileiro de Controle do Câncer
Principal Investigator:Sandra Serrano, MDFundacao Antonio Prudente - Hospital A.C. Camargo/Hospital do Cancer
Principal Investigator:Martin Smakal, MDOncology department of Nemocnice Benesov
Principal Investigator:Jiri Klecka, MDResearch Site Ltd
Principal Investigator:Petra Panovcova, MDNemocnice Horovice
Principal Investigator:Ondrej Slama, MDMasarykuv onkologicky ustav, Klinika komplexni onkologicke pece
Principal Investigator:Zbigniew Nowecki, MDMSCM Cancer Center and Institute Oncology
Principal Investigator:Viliam Cibik, MDSlovak Research Center
Principal Investigator:Lubomira Nemcikova, MDNeurology and pain out patient clinic/NCI
Principal Investigator:Keon Uk Park, MDDepartment of Oncology/Keimyung University Dongsan Medical Center
Principal Investigator:Joo Hyuk Sohn, MDSeverance Hospital
Principal Investigator:Marie Fallon, MDEdinburgh Cancer Research Centre (IGMM)
Principal Investigator:Peter Barrett-Lee, MDVelindre Cancer Centre
Principal Investigator:Alejandro Orts Castro, MDHospital Sanitas La Moraleja
Principal Investigator:Lee Na Teo, MDBallarat Health Services
Principal Investigator:Giuliano Borges, MDClinica de Neuoplasias Litoral - Centro de Novos Tratamentos Itajaí
Principal Investigator:Tiago Biachi de Castria, MDInstituto do Cancer do Estado de Sao Paulo
Principal Investigator:Jung Hye Kwon, MDHallym University Kangdong Sacred Heart Hospital
Principal Investigator:Pavol Demo, MDAmbulancia Klinickej onkologie FNsP Nove Zamky
Principal Investigator:Jitka Fricova, MDGeneral University Hospital
Principal Investigator:Georg Nuhr, MDNuhr Medical Center
Principal Investigator:Patricia Santi, MDFaculdade de Medicina do ABC/CEPHO - Centro de Estudos e Pesquisa em Hematologia e Oncologia
Principal Investigator:Susanne Costa, MDInstituto Nacional de Câncer - INCA
Principal Investigator:Philippe Poulain, MDPolyclinique de L'ormeau
Principal Investigator:Andrzej Stachowiak, MDPallmed Sp. z o.o. NZOZ Dom Sue Ryder
Principal Investigator:Maciej Sopata, MDPoradnia Medycyny Paliatywnej Hospicjum Palium
Principal Investigator:Carlos Jara Sanchez, MDHospital Universitario Fundacion de Alcorcon
Principal Investigator:Maria Salete Nascimento, MDHospital do Cancer de Barretos Fundacao Pio XII
Principal Investigator:Tatiana Pietrzynska, MDPowiatowy Zespo Zakadow Opieki Zdrowotnej w Bdzinie, Oddzia Opieki Paliatywnej Szpital Czelad
Principal Investigator:Agnieszka Kluczna, MDNiepliczny Zakad Opieki Zdrowotnej Zespo Medyczno-Opieku-Czy Alicja Kluczna
Principal Investigator:Ancor Serrano Afonso, MDL'Hospitalet de Llobregat
Principal Investigator:Michael Franco, MDMonash Medical Centre - Moorabin Campus
Principal Investigator:Magdalena Korozan, MDHospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku
Principal Investigator:Marcin Janecki, MDStowarzyszenie Przyjacio Chorych Hospicjum w Gliwicach NZOZ Hospicjum Miosierdzia Boego
Principal Investigator:Hedviga Jakubikova, MDSanera, s.r.o. Neurologicka a algeziologicka ambulancia
Principal Investigator:César Margarit Ferri, MDHospital General Universitario Dd Alicante
Principal Investigator:Tae-Yong Kim, MDDepartment of Oncology/ Seoul National University Hospital
Principal Investigator:Concepción Pérez Hernández, MDHospital Universitario La Princesa
Principal Investigator:Dirk Forstmeyer, MDUniversitätsklinikum Leipzig AöR Universitäres Krebszentrum Leipzig (UCCL)
Principal Investigator:Tibor Csoszi, MDHetenyi G Korhaz
Principal Investigator:Laszlo Landherr, MDUzsoki utcai Kórház
Principal Investigator:Andras Telekes, MDBajcsy-Zsilinszy Hospital
Principal Investigator:Roxana Ioana Scheusan, MDOncocenter Onclogie Clinica S.R.L
Principal Investigator:Dan Lungulescu, MDSC Oncolab SRL
Principal Investigator:Carmen Crihana, MDDepartment of Oncology at CF Clinical Hospital
Principal Investigator:Burkhard Gustorff, MDWilhelminenspital der Stadt Wien
Principal Investigator:Zsofia Polya, MDJosa András Teaching Hospital
Principal Investigator:Jinsoo Chung, MDNational Cancer Center
Principal Investigator:Michael Schenker, MDSF Nectarie Oncology Centre
Principal Investigator:Maria Goretti Pazos Gonzalez, MDComplexo Hospitalario Universitario A Coruna
Principal Investigator:Han Yong Choi, MDSamsung Medical Center
Principal Investigator:Raúl Sala, MDInstituto de Oncologia de Rosario
Principal Investigator:Juan Cúndom, MDFundacion Favaloro Para La Docencia e Investigacion Medica
Principal Investigator:Medgyasszay Balazs, MDVeszprém Megyei Tüd?gyógyintézet Farkasgyep?
Principal Investigator:Tamás Pintér, MDPetz Aladár Country Teaching Hospital Gyor
Principal Investigator:Thomas Cuvier, MDDepartmental Hosptital of Vendee
Principal Investigator:Lynn Maeda, MDNishinomiya Municipal Central Hospital
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP