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A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

Primary Purpose

Neoplasm Metastasis, Palliative Care

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tanezumab 10 mg IV
IV Placebo for tanezumab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain.
  • Requires daily opioid medication

Exclusion Criteria:

  • Patients who do not have bone pain caused by cancer are not eligible for the study.
  • Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible.
  • Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening.
  • Known history of rheumatoid arthritis.

Sites / Locations

  • UCSD Center for Pain Medicine
  • UCSD Medical Center - Thornton Hospital
  • UCSD Moores Cancer Center
  • Indiana Pain and Spine Clinic
  • WK River Cities Clinical Research Center
  • Willis Knighton Pierremont Health Center
  • Hollings Cancer Center
  • Medical University of South Carolina, Department of Urology
  • MUSC Department of Radiology
  • MUSC Investigational Pharmacy
  • MUSC Urology Ambulatory Care
  • Huntsman Cancer Institute at the University of Utah
  • Landeskrankenhaus Graz - Universitaetsklinik fuer Orthopaedie und Orthopaedische Chirurgie
  • Krankenhaus der Elisabethinen Linz, Institut fuer Anaesthesiologie und Intensivmedizin
  • Nuhr Zentrum
  • Clinic of Oncology
  • Institute of Oncology, University Clinical Center Sarajevo
  • General Hospital Varazdin
  • Institut Gustave Roussy
  • Fovarosi Onkormanyzat Peterfy Sandor Utcai Korhaz - Fajdalom Ambulancia
  • Fovarosi Onkormanyzat Jahn Ferenc Del-pesti Korhaz - Fajdalom Ambulancia
  • Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly
  • Shri Siddhivinayak Ganpati Cancer Hospital
  • Central India Cancer Research Institute
  • Shatabdi Superspeciality Hospital
  • Chhatrapati Shahuji Maharaj Medical University
  • Rajiv Gandhi Cancer Institute and Research Centre,
  • Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
  • Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
  • 10th Department, Latvian Oncological Centre / Riga Eastern Clinical University Hospital
  • Centro de Cancer del Centro Medico ABC
  • Hospital Nacional Guillermo Almenara Irigoyen
  • Oncocare
  • Niepubliczny Zaklad Opieki Zdrowotnej
  • Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku
  • Poradnia Medycyny Paliatywnej, Hospicjum Palium
  • NZOZ Zespol Opieki Domowej
  • Fakultna Nemocnica s Poliklinikou F.D.Roosevelta
  • Narodny onkologicky ustav

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tanezumab 10 mg IV + opioids

Placebo + opioids

Arm Description

Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.

Outcomes

Primary Outcome Measures

Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser the pain intensity.

Secondary Outcome Measures

Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser pain intensity.
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
The worst pain was assessed an 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser pain intensity.
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF)
The worst pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The lower the value the lesser pain intensity.
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to10 (Pain as bad as you can imagine), lower scores indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point NRS at 0 (Does not interfere) to 10 (Completely interferes).
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower score indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores =lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores=lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF
Percentage of participant with response as defined by a >=30%, >=50%, >=70%, and >=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower scores indicate less pain intensity.
Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF
Percentage of participant with response as defined by a >=30%, >=50%, >=70%, and >=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower scores indicate less pain intensity
Average Daily Opioid Consumption
The average daily opioid consumption was calculated as the daily sum of total opioid dosage in milligrams. Opioid consumption on each day was converted to the morphine equivalent dosage (MED). Results were summarized for opioid dose adjust period, baseline assessment period and post-baseline period.
Number of Doses of Rescue Medication Required Per Week
Participants received immediate release (IR) opioid as rescue medication as needed for breakthrough pain from Day 1-113 at the dose determined during the pre-treatment phase, provided the average total daily dose of opioids between study visits does not exceed the baseline total daily opioid dose by more than 10%.
Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16
OR-SDS: participant-rated levels of frequency (F), severity (S), degree of bother (DoB) for 10 symptoms: fatigue, drowsiness, concentration, confusion, nausea, dizziness, constipation, itching, difficulty with urination, retching/vomiting. For each symptom levels of F, S and DoB scored as: frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'). Mean of F, S and DoB was calculated for each symptom to derive composite scores/multi-domain average (MDA) scores which ranges from 0 to 4.33. Higher MDA=worse symptom. Composite scores for frequency (FCS), severity (SCS), degree of bother, and MDA were calculated as mean of these scores across 10 symptoms and had same ranges as individual scores frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'); higher scores=more distress
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual scores and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual items and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.
Patient's Global Evaluation of Study Medication
The Patient's Global Evaluation of Study Medication (PGESM) was a single item that assessed the participant's perception of his/her response to the study medication. It was a self-administered question that utilizes a 4-point Likert scale from 1="Poor" to 4="Excellent", where higher score represented better outcome.
Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of 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 are events between first dose of study drug and up to 113 days that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Physical Examination Abnormalities
Physical examinations included general appearance (skin, neck, eyes, ears, nose, throat), cardiovascular system (including rhythm and presence of other cardiac abnormalities, such as gallops, murmurs, and cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system, and any additional assessments necessary to establish baseline status or evaluate symptoms or adverse experiences. Abnormalities in physical examination was based on investigator's discretion.
Number of Participants With Abnormal Neurological Examination
Neurological examinations assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index finger and great toes in order to complete the neuropathy impairment score (NIS). NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis) for muscle strength, higher score indicated higher abnormality/impairment, and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent) for sensation, higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Vital Sign Examination: Body Temperature
Vital Sign Examination: Blood Pressure (BP)
Systolic BP: the measurement of the pressure when the heart is contracted (systole). The systolic pressure indicates the maximum amount of work/force the heart has to perform with each stroke in order to move blood through the arteries. Diastolic BP: the pressure in the large arteries during the relaxation of the left ventricle. The diastolic pressure indicates the amount of pressure the heart must overcome in order to generate the next beat.
Vital Sign Examination: Respiratory Rate
Respiration rate measured as number of breaths taken per minute.
Vital Sign Examination: Heart Rate
Heart rate is the number of heart beats per minute.
Body Weight of Participants
Number of Participants With Abnormal Laboratory Examination
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (<0.8*lower limit of normal [LLN]); red blood cell count (<0.8*LLN); platelets (<0.5*LLN or >1.75* upper limit of normal [ULN]); leucocytes (<0.6*LLN or >1.5*ULN); lymphocytes, total neutrophils (<0.8*LLN or >1.2*ULN); basophils, eosinophils, monocytes (>1.2*ULN); total bilirubin (>1.5* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN or >1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN or 1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN or 1.1*ULN); albumin, total protein (<0.8*LLN or 1.2*ULN); urine analysis. Total number of participants without regards to baseline abnormality was summarized.
Number of Participants With Anti-drug Antibodies
Human serum samples were analyzed using electrochemiluminescent (ECL) immunoassay for the presence of anti-tanezumab antibodies. Same participant may have positive (titer value >=4.32) anti-tanezumab antibodies result at more than 1 time point.
Electrocardiogram Examination
ECG intervals included: RR (the time interval between consecutive heart beats), PR (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS (represented ventricular depolarization) and QT (time corresponding to the beginning of depolarization to repolarization of the ventricles), QTcF (QT interval corrected using Fridericia's formula [FF]), QTcB interval (QT interval corrected using Bazett's formula [BF]).
Electrocardiogram Examination: Heart Rate
Standard 12-lead ECG performed after participant had rested quietly for at least 10 minutes in a supine position was measured. The time interval between consecutive heart beats [RR interval] (in beats per minute [bpm]) was used to calculate heart rate.

Full Information

First Posted
October 15, 2007
Last Updated
May 24, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00545129
Brief Title
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
Official Title
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 29, 2009 (Actual)
Primary Completion Date
December 24, 2011 (Actual)
Study Completion Date
February 7, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Palliative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tanezumab 10 mg IV + opioids
Arm Type
Experimental
Arm Title
Placebo + opioids
Arm Type
Placebo Comparator
Arm Description
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
Intervention Type
Drug
Intervention Name(s)
Tanezumab 10 mg IV
Intervention Description
Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.
Intervention Type
Drug
Intervention Name(s)
IV Placebo for tanezumab
Intervention Description
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
Description
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser the pain intensity.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Description
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser pain intensity.
Time Frame
Baseline, Weeks 1, 2, 4, 8, 12, 16
Title
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description
The worst pain was assessed an 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser pain intensity.
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description
The worst pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The lower the value the lesser pain intensity.
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
Description
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to10 (Pain as bad as you can imagine), lower scores indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point NRS at 0 (Does not interfere) to 10 (Completely interferes).
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF
Description
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower score indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
Description
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores =lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF
Description
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores=lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF
Description
Percentage of participant with response as defined by a >=30%, >=50%, >=70%, and >=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower scores indicate less pain intensity.
Time Frame
Week 1, 2, 4, 6, 8, 12, 16
Title
Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF
Description
Percentage of participant with response as defined by a >=30%, >=50%, >=70%, and >=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower scores indicate less pain intensity
Time Frame
Week 1, 2, 4, 6, 8, 12, 16
Title
Average Daily Opioid Consumption
Description
The average daily opioid consumption was calculated as the daily sum of total opioid dosage in milligrams. Opioid consumption on each day was converted to the morphine equivalent dosage (MED). Results were summarized for opioid dose adjust period, baseline assessment period and post-baseline period.
Time Frame
Opioid Dose Adjust Period (Day-30 to Day-4), Baseline Assessment period (Day-3 to Day-1), Post Baseline Period (Day 1 to Week 16)
Title
Number of Doses of Rescue Medication Required Per Week
Description
Participants received immediate release (IR) opioid as rescue medication as needed for breakthrough pain from Day 1-113 at the dose determined during the pre-treatment phase, provided the average total daily dose of opioids between study visits does not exceed the baseline total daily opioid dose by more than 10%.
Time Frame
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
Title
Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16
Description
OR-SDS: participant-rated levels of frequency (F), severity (S), degree of bother (DoB) for 10 symptoms: fatigue, drowsiness, concentration, confusion, nausea, dizziness, constipation, itching, difficulty with urination, retching/vomiting. For each symptom levels of F, S and DoB scored as: frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'). Mean of F, S and DoB was calculated for each symptom to derive composite scores/multi-domain average (MDA) scores which ranges from 0 to 4.33. Higher MDA=worse symptom. Composite scores for frequency (FCS), severity (SCS), degree of bother, and MDA were calculated as mean of these scores across 10 symptoms and had same ranges as individual scores frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'); higher scores=more distress
Time Frame
Baseline, Week 2, 4, 6, 12, 16
Title
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
Description
Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual scores and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
Description
Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual items and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Patient's Global Evaluation of Study Medication
Description
The Patient's Global Evaluation of Study Medication (PGESM) was a single item that assessed the participant's perception of his/her response to the study medication. It was a self-administered question that utilizes a 4-point Likert scale from 1="Poor" to 4="Excellent", where higher score represented better outcome.
Time Frame
Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
Description
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
Description
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF
Description
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time Frame
Week 1, 2, 4, 6, 8, 12, 16
Title
Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF
Description
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time Frame
Week 1, 2, 4, 6, 8, 12, 16
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of 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 are events between first dose of study drug and up to 113 days that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Baseline up to 113 days
Title
Number of Participants With Physical Examination Abnormalities
Description
Physical examinations included general appearance (skin, neck, eyes, ears, nose, throat), cardiovascular system (including rhythm and presence of other cardiac abnormalities, such as gallops, murmurs, and cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system, and any additional assessments necessary to establish baseline status or evaluate symptoms or adverse experiences. Abnormalities in physical examination was based on investigator's discretion.
Time Frame
Baseline up to Week 16 or Early Termination (up to 113 days)
Title
Number of Participants With Abnormal Neurological Examination
Description
Neurological examinations assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index finger and great toes in order to complete the neuropathy impairment score (NIS). NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis) for muscle strength, higher score indicated higher abnormality/impairment, and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent) for sensation, higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Time Frame
Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Title
Vital Sign Examination: Body Temperature
Time Frame
Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Title
Vital Sign Examination: Blood Pressure (BP)
Description
Systolic BP: the measurement of the pressure when the heart is contracted (systole). The systolic pressure indicates the maximum amount of work/force the heart has to perform with each stroke in order to move blood through the arteries. Diastolic BP: the pressure in the large arteries during the relaxation of the left ventricle. The diastolic pressure indicates the amount of pressure the heart must overcome in order to generate the next beat.
Time Frame
Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Title
Vital Sign Examination: Respiratory Rate
Description
Respiration rate measured as number of breaths taken per minute.
Time Frame
Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Title
Vital Sign Examination: Heart Rate
Description
Heart rate is the number of heart beats per minute.
Time Frame
Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, and Early Termination (up to 113 days)
Title
Body Weight of Participants
Time Frame
Baseline, Week 6, 16 and Early Termination (up to 113 days)
Title
Number of Participants With Abnormal Laboratory Examination
Description
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (<0.8*lower limit of normal [LLN]); red blood cell count (<0.8*LLN); platelets (<0.5*LLN or >1.75* upper limit of normal [ULN]); leucocytes (<0.6*LLN or >1.5*ULN); lymphocytes, total neutrophils (<0.8*LLN or >1.2*ULN); basophils, eosinophils, monocytes (>1.2*ULN); total bilirubin (>1.5* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN or >1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN or 1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN or 1.1*ULN); albumin, total protein (<0.8*LLN or 1.2*ULN); urine analysis. Total number of participants without regards to baseline abnormality was summarized.
Time Frame
Baseline up to Week 16, Early Termination (up to 113 days)
Title
Number of Participants With Anti-drug Antibodies
Description
Human serum samples were analyzed using electrochemiluminescent (ECL) immunoassay for the presence of anti-tanezumab antibodies. Same participant may have positive (titer value >=4.32) anti-tanezumab antibodies result at more than 1 time point.
Time Frame
Baseline (Day 1), Week 4, 6, 12, 16
Title
Electrocardiogram Examination
Description
ECG intervals included: RR (the time interval between consecutive heart beats), PR (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS (represented ventricular depolarization) and QT (time corresponding to the beginning of depolarization to repolarization of the ventricles), QTcF (QT interval corrected using Fridericia's formula [FF]), QTcB interval (QT interval corrected using Bazett's formula [BF]).
Time Frame
Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days)
Title
Electrocardiogram Examination: Heart Rate
Description
Standard 12-lead ECG performed after participant had rested quietly for at least 10 minutes in a supine position was measured. The time interval between consecutive heart beats [RR interval] (in beats per minute [bpm]) was used to calculate heart rate.
Time Frame
Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain. Requires daily opioid medication Exclusion Criteria: Patients who do not have bone pain caused by cancer are not eligible for the study. Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible. Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening. Known history of rheumatoid arthritis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Center for Pain Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-7651
Country
United States
Facility Name
UCSD Medical Center - Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-7651
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Indiana Pain and Spine Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
WK River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Willis Knighton Pierremont Health Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina, Department of Urology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Department of Radiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Investigational Pharmacy
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Urology Ambulatory Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Landeskrankenhaus Graz - Universitaetsklinik fuer Orthopaedie und Orthopaedische Chirurgie
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz, Institut fuer Anaesthesiologie und Intensivmedizin
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Nuhr Zentrum
City
Senftenberg
ZIP/Postal Code
A-3541
Country
Austria
Facility Name
Clinic of Oncology
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Institute of Oncology, University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
General Hospital Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Fovarosi Onkormanyzat Peterfy Sandor Utcai Korhaz - Fajdalom Ambulancia
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Jahn Ferenc Del-pesti Korhaz - Fajdalom Ambulancia
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly
City
Szekesfehervar
ZIP/Postal Code
8003
Country
Hungary
Facility Name
Shri Siddhivinayak Ganpati Cancer Hospital
City
Miraj
State/Province
Maharashtra
ZIP/Postal Code
416 410
Country
India
Facility Name
Central India Cancer Research Institute
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440 010
Country
India
Facility Name
Shatabdi Superspeciality Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 005
Country
India
Facility Name
Chhatrapati Shahuji Maharaj Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Rajiv Gandhi Cancer Institute and Research Centre,
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
10th Department, Latvian Oncological Centre / Riga Eastern Clinical University Hospital
City
Riga
ZIP/Postal Code
LV 1079
Country
Latvia
Facility Name
Centro de Cancer del Centro Medico ABC
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen
City
Lima
State/Province
Lima L13
Country
Peru
Facility Name
Oncocare
City
Lima
ZIP/Postal Code
05127
Country
Peru
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku
City
Gdansk
ZIP/Postal Code
80-208
Country
Poland
Facility Name
Poradnia Medycyny Paliatywnej, Hospicjum Palium
City
Poznan
ZIP/Postal Code
61-245
Country
Poland
Facility Name
NZOZ Zespol Opieki Domowej
City
Wloclawek
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Fakultna Nemocnica s Poliklinikou F.D.Roosevelta
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
25919474
Citation
Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211.
Results Reference
derived
PubMed Identifier
21941281
Citation
Bapat AA, Hostetter G, Von Hoff DD, Han H. Perineural invasion and associated pain in pancreatic cancer. Nat Rev Cancer. 2011 Sep 23;11(10):695-707. doi: 10.1038/nrc3131.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091003&StudyName=A%20Study%20Of%20Tanezumab%20as%20Add-On%20Therapy%20to%20Opioid%20Medication%20In%20Patients%20With%20Pain%20Due%20To%20Cancer%20That%20Has%20Spread%20To%20Bone
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

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