Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 37 for:    Recruiting Studies | Multiple Myeloma | Spain | ( Map: Spain )

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02609828
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Musculoskeletal Pain Drug: Tanezumab Phase 3

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 28, 2015
Estimated Primary Completion Date : March 22, 2020
Estimated Study Completion Date : January 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Tanezumab 20 mg subcutaneously
Drug: Tanezumab
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Other Name: PF-04383119

Placebo Comparator: Arm 2
Placebo matched to active treatment subcutaneously
Drug: Tanezumab
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Other Name: PF-04383119




Primary Outcome Measures :
  1. Change from baseline in daily average pain intensity in index bone metastasis cancer pain site [ Time Frame: 8 weeks ]
    Change from Baseline to Week 8 in the daily average pain intensity Numerical Rating Score (NRS) in the index bone metastasis cancer pain site.


Secondary Outcome Measures :
  1. Change from baseline in daily average pain intensity in index bone metastasis cancer pain site [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 1, 2, 4, 6, 12, 16 and 24 in the daily average pain intensity NRS score in the index bone metastasis cancer pain site.

  2. Change from baseline in daily worst pain intensity in index bone metastasis cancer pain site [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 in the daily worst pain intensity NRS score in the index bone metastasis cancer pain site.

  3. Change from baseline in weekly average pain intensity in non-index cancer pain sites [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 in the weekly average pain intensity NRS score in non-index cancer pain sites.

  4. Change from baseline in weekly worst pain intensity in non-index cancer pain sites [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 in the weekly worst pain intensity NRS score in non-index cancer pain sites.

  5. Change from baseline in daily average pain intensity in non-index visceral cancer pain sites [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 in the daily average pain intensity NRS score in the non-index visceral cancer pain sites.

  6. Change from baseline in daily worst pain intensity in non-index visceral cancer pain sites [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 in the daily worst pain intensity NRS score in the non-index visceral cancer pain sites.

  7. Change from baseline in Brief Pain Inventory (BPI) average pain score [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 2, 4, 8, 16 and 24 in the Brief Pain Inventory (BPI) average pain scores obtained at study visits.

  8. Change from baseline in BPI worst pain score [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 2, 4, 8, 16 and 24 in the BPI worst pain scores obtained at study visits.

  9. Response as defined by a 30%, 50%, 70%, and 90% reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site [ Time Frame: Up to 24 weeks ]
    Response as defined by a 30%, 50%, 70%, and 90% reduction from baseline in the daily average and 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.

  10. Change from baseline in Patient's Global Assessment of Cancer Pain [ Time Frame: Up to 24 weeks ]
    Change from Baseline in Patient's Global Assessment of Cancer Pain at Weeks 2, 4, 8, 16 and 24.

  11. Response defined as an improvement of 2 points in Patient's Global Assessment of Cancer Pain [ Time Frame: Up to 24 weeks ]
    Response defined as an improvement of 2 points in Patient's Global Assessment of Cancer Pain at Weeks 2, 4, 8, 16 and 24.

  12. Change from baseline in the BPI Pain Interference with Function composite score and individual pain interference item scores [ Time Frame: Up to 24 weeks ]
    Change from Baseline to Weeks 2, 4, 8, 16 and 24 in the BPI Pain Interference with Function Composite Score and individual pain interference item scores obtained at study visits.

  13. EuroQol 5 Dimension (EQ-5D-5L) dimensions and overall health utility score [ Time Frame: Up to 24 weeks ]
    EuroQol 5 Dimension (EQ-5D-5L) dimensions and overall health utility score at Baseline and Weeks 8, 16 and 24.

  14. Average daily total opioid consumption (in mg of morphine equivalent doses) [ Time Frame: Up to 24 weeks ]
    Average daily total opioid consumption (in mg of morphine equivalent doses) at Weeks 1, 2, 4, 6, 8, 12, 16 and 24.

  15. Average number of doses of rescue medication required per week [ Time Frame: Up to 24 weeks ]
    Average number of doses of rescue medication required per week at Weeks 1, 2, 4, 6, 8, 12, 16 and 24.

  16. Change from baseline in weekly Opioid-Related Symptom Distress Scale [ Time Frame: Up to 24 weeks ]
    Change from Baseline in the weekly Opioid-Related Symptom Distress Scale at Weeks 2, 4, 8, 16, and 24.

  17. Adverse events [ Time Frame: Up to 48 weeks ]
    Summary listing of adverse events for each participant; Summary of risk differences between each tanezumab group and placebo for common adverse events and for selected adverse events of interest.

  18. Standard safety assessments [ Time Frame: Up to 48 weeks ]
    Summary listing of safety laboratory testing [chemistry, hematology], sitting vital signs, ECG [12-lead]) for each participant.

  19. Orthostatic (supine/standing) blood pressure assessment [ Time Frame: Up to 48 weeks ]
    Orthostatic (supine/standing) blood pressure assessment.

  20. Weight and Height measurements, Physical examinations. [ Time Frame: Up to 48 weeks ]
    Weight measurements (pounds or kilograms), Height measurements (inches or centimeters), Body Mass Index (kg per meter squared), Physical examinations.

  21. Neurologic examination (Neuropathy Impairment Score [NIS]). [ Time Frame: Up to 48 weeks ]
    Neurologic examination (Neuropathy Impairment Score [NIS]).

  22. Survey of Autonomic Symptom scores [ Time Frame: Up to 48 weeks ]
    Survey of Autonomic Symptom scores.

  23. Anti-drug antibody (ADA) assessments [ Time Frame: Up to 48 weeks ]
    Anti-drug antibody (ADA) assessments.

  24. Joint safety adjudication outcomes [ Time Frame: Up to 48 weeks, or up to 24 weeks following total joint replacement procedure ]
    Number of subjects with adjudicated events of rapidly progressive osteoarthritis type 2, subchondral insufficiency fractures or spontaneous osteonecrosis of the knee, primary osteonecrosis, or pathological fracture.

  25. Total joint replacements [ Time Frame: Up to 24 weeks post-procedure ]
    Total joint replacements



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609828


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 109 Study Locations
Sponsors and Collaborators
Pfizer
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Christos Karapetis, MD Flinders cancer innovation centre, Flinders Medical Centre
Principal Investigator: Patricia Milhomem, MD Centro de Pesquisas Clinicas da Fundação Hospital Amaral Carvalho
Principal Investigator: Fernanda Damian, MD União Brasileira de Educação e Assintência Hospital Sao Lucas DA PUCRS
Principal Investigator: Rudolf Likar, MD Dep. of Anesthesiology and Intensiv Care Medicine, Klinikum Klagenfurt
Principal Investigator: Ludmila Koch, MD Hospital Israelita Albert Einstein
Principal Investigator: Felipe Cruz, MD IBCC - Instituto Brasileiro de Controle do Câncer
Principal Investigator: Sandra Serrano, MD Fundacao Antonio Prudente - Hospital A.C. Camargo/Hospital do Cancer
Principal Investigator: Martin Smakal, MD Oncology department of Nemocnice Benesov
Principal Investigator: Jiri Klecka, MD Research Site Ltd
Principal Investigator: Petra Panovcova, MD Nemocnice Horovice
Principal Investigator: Ondrej Slama, MD Masarykuv onkologicky ustav, Klinika komplexni onkologicke pece
Principal Investigator: Zbigniew Nowecki, MD MSCM Cancer Center and Institute Oncology
Principal Investigator: Viliam Cibik, MD Slovak Research Center
Principal Investigator: Lubomira Nemcikova, MD Neurology and pain out patient clinic/NCI
Principal Investigator: Keon Uk Park, MD Department of Oncology/Keimyung University Dongsan Medical Center
Principal Investigator: Joo Hyuk Sohn, MD Severance Hospital
Principal Investigator: Marie Fallon, MD Edinburgh Cancer Research Centre (IGMM)
Principal Investigator: Peter Barrett-Lee, MD Velindre Cancer Centre
Principal Investigator: Alejandro Orts Castro, MD Hospital Sanitas La Moraleja
Principal Investigator: Lee Na Teo, MD Ballarat Health Services
Principal Investigator: Giuliano Borges, MD Clinica de Neuoplasias Litoral - Centro de Novos Tratamentos Itajaí
Principal Investigator: Tiago Biachi de Castria, MD Instituto do Cancer do Estado de Sao Paulo
Principal Investigator: Jung Hye Kwon, MD Hallym University Kangdong Sacred Heart Hospital
Principal Investigator: Pavol Demo, MD Ambulancia Klinickej onkologie FNsP Nove Zamky
Principal Investigator: Jitka Fricova, MD General University Hospital
Principal Investigator: Georg Nuhr, MD Nuhr Medical Center
Principal Investigator: Patricia Santi, MD Faculdade de Medicina do ABC/CEPHO - Centro de Estudos e Pesquisa em Hematologia e Oncologia
Principal Investigator: Susanne Costa, MD Instituto Nacional de Câncer - INCA
Principal Investigator: Philippe Poulain, MD Polyclinique de L'ormeau
Principal Investigator: Andrzej Stachowiak, MD Pallmed Sp. z o.o. NZOZ Dom Sue Ryder
Principal Investigator: Maciej Sopata, MD Poradnia Medycyny Paliatywnej Hospicjum Palium
Principal Investigator: Carlos Jara Sanchez, MD Hospital Universitario Fundacion de Alcorcon
Principal Investigator: Maria Salete Nascimento, MD Hospital do Cancer de Barretos Fundacao Pio XII
Principal Investigator: Tatiana Pietrzynska, MD Powiatowy Zespo Zakadow Opieki Zdrowotnej w Bdzinie, Oddzia Opieki Paliatywnej Szpital Czelad
Principal Investigator: Agnieszka Kluczna, MD Niepliczny Zakad Opieki Zdrowotnej Zespo Medyczno-Opieku-Czy Alicja Kluczna
Principal Investigator: Ancor Serrano Afonso, MD L'Hospitalet de Llobregat
Principal Investigator: Michael Franco, MD Monash Medical Centre - Moorabin Campus
Principal Investigator: Magdalena Korozan, MD Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku
Principal Investigator: Marcin Janecki, MD Stowarzyszenie Przyjacio Chorych Hospicjum w Gliwicach NZOZ Hospicjum Miosierdzia Boego
Principal Investigator: Hedviga Jakubikova, MD Sanera, s.r.o. Neurologicka a algeziologicka ambulancia
Principal Investigator: César Margarit Ferri, MD Hospital General Universitario Dd Alicante
Principal Investigator: Tae-Yong Kim, MD Department of Oncology/ Seoul National University Hospital
Principal Investigator: Concepción Pérez Hernández, MD Hospital Universitario La Princesa
Principal Investigator: Dirk Forstmeyer, MD Universitätsklinikum Leipzig AöR Universitäres Krebszentrum Leipzig (UCCL)
Principal Investigator: Tibor Csoszi, MD Hetenyi G Korhaz
Principal Investigator: Laszlo Landherr, MD Uzsoki utcai Kórház
Principal Investigator: Andras Telekes, MD Bajcsy-Zsilinszy Hospital
Principal Investigator: Roxana Ioana Scheusan, MD Oncocenter Onclogie Clinica S.R.L
Principal Investigator: Dan Lungulescu, MD SC Oncolab SRL
Principal Investigator: Carmen Crihana, MD Department of Oncology at CF Clinical Hospital
Principal Investigator: Burkhard Gustorff, MD Wilhelminenspital der Stadt Wien
Principal Investigator: Zsofia Polya, MD Josa András Teaching Hospital
Principal Investigator: Jinsoo Chung, MD National Cancer Center
Principal Investigator: Michael Schenker, MD SF Nectarie Oncology Centre
Principal Investigator: Maria Goretti Pazos Gonzalez, MD Complexo Hospitalario Universitario A Coruna
Principal Investigator: Han Yong Choi, MD Samsung Medical Center
Principal Investigator: Raúl Sala, MD Instituto de Oncologia de Rosario
Principal Investigator: Juan Cúndom, MD Fundacion Favaloro Para La Docencia e Investigacion Medica
Principal Investigator: Medgyasszay Balazs, MD Veszprém Megyei Tüdőgyógyintézet Farkasgyepű
Principal Investigator: Tamás Pintér, MD Petz Aladár Country Teaching Hospital Gyor
Principal Investigator: Thomas Cuvier, MD Departmental Hosptital of Vendee
Principal Investigator: Lynn Maeda, MD Nishinomiya Municipal Central Hospital

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02609828     History of Changes
Other Study ID Numbers: A4091061
2013-002223-42 ( EudraCT Number )
CANCER PAIN PH 3 SC STUDY ( Other Identifier: Alias Study Number )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Metastatic cancer bone pain
Multiple myeloma

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Cancer Pain
Musculoskeletal Pain
Neoplastic Processes
Neoplasms
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Tanezumab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs