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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02609828




Registration number
NCT02609828
Ethics application status
Date submitted
26/10/2015
Date registered
20/11/2015

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2013-002223-42
Secondary ID [2] 0 0
A4091061
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Metastasis 0 0
Cancer Pain 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tanezumab

Experimental: Arm 1 - Tanezumab 20 mg subcutaneously

Placebo comparator: Arm 2 - Placebo matched to active treatment subcutaneously


Treatment: Drugs: Tanezumab
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8
Assessment method [1] 0 0
Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8.
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [1] 0 0
Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24
Assessment method [1] 0 0
Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain) where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 12, 16 and 24 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the each specified week.
Timepoint [1] 0 0
Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24
Secondary outcome [2] 0 0
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [2] 0 0
Daily worst pain intensity in the index bone metastasis cancer pain site is assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. The participants describe their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily worst pain intensity was mean of daily worst pain intensity NRS score during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 daily worst pain intensity value was the mean of the daily worst pain intensity NRS scores recorded for each of the 7 days prior to the each specified week.
Timepoint [2] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [3] 0 0
Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [3] 0 0
Weekly average pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants described their weekly pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly average pain intensity was weekly average pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly average pain intensity value was the weekly average pain intensity NRS scores recorded on any day from the span of 7 days prior to specified week.
Timepoint [3] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [4] 0 0
Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [4] 0 0
Weekly worst pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants describe their weekly worst pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly worst pain intensity was weekly worst pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly worst pain intensity value was the weekly worst pain intensity NRS scores which was recorded on any day from the span of 7 days prior to specified week.
Timepoint [4] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [5] 0 0
Change From Baseline in the Daily Average Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [5] 0 0
Daily average pain intensity in the non-index visceral cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants described their pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline is defined as the mean average daily pain intensity NRS score during the baseline assessment period prior to randomization. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily average pain intensity scores for the 7 days prior to the each specified week.
Timepoint [5] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [6] 0 0
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [6] 0 0
Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week.
Timepoint [6] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [7] 0 0
Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [7] 0 0
Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily average pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily average pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.
Timepoint [7] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [8] 0 0
Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [8] 0 0
Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.
Timepoint [8] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [9] 0 0
Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24
Assessment method [9] 0 0
Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition.
Timepoint [9] 0 0
Baseline, Weeks 2, 4, 8, 16 and 24
Secondary outcome [10] 0 0
Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24
Assessment method [10] 0 0
Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores:1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition.
Timepoint [10] 0 0
Baseline, Weeks 2, 4, 8, 16 and 24
Secondary outcome [11] 0 0
Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [11] 0 0
In this outcome measure average daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED).
Timepoint [11] 0 0
Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [12] 0 0
Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Assessment method [12] 0 0
In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported.
Timepoint [12] 0 0
Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [13] 0 0
Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24
Assessment method [13] 0 0
OR-SDS: questionnaire evaluated opioid-related 12 symptoms. For each symptom, participants assigned integer scores to assess severity (none =0 to very severe =4), distress (none =0 to very much =5), and frequency (none =0 to almost constantly =4; participants reported number of retching/vomiting episodes (none =0, 1-2 episodes =1, 3-4 episodes =2, 5-6 episodes =3, \>6 episodes =4). Frequency composite score: mean of frequency scores from all symptoms, ranged from 0 (none) to 4 (almost constantly); higher scores = worse condition. Severity composite score: mean of severity scores from all 12 symptoms, ranged from 0 (none) to 4 (maximum severity); higher scores = worse condition. Distress composite score: mean of distress scores from all 12 symptoms, ranged from 0 (none) to 5 (maximum distress); higher scores = worse condition. Multi domain average (MDA): average of each symptom for frequency, severity, and distress; ranged from 0 (none) to 4.34 (worse); higher scores = worse condition.
Timepoint [13] 0 0
Baseline, Weeks 2, 4, 8, 16, and 24
Secondary outcome [14] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Assessment method [14] 0 0
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks post last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. Participants were followed up to 24 weeks after study drug last dose.
Timepoint [14] 0 0
Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
Secondary outcome [15] 0 0
Number of Participants With Laboratory Abnormalities (Normal Baseline)
Assessment method [15] 0 0
Laboratory abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes \< 0.8\*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio \>1.1\*ULN; bilirubin \>1.5\*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, creatinine, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; Urine: glucose, ketones, protein, HGB, bilirubin, nitrite \>=1.
Timepoint [15] 0 0
Baseline (Day 1, before dosing) up to Week 48
Secondary outcome [16] 0 0
Number of Participants With Laboratory Abnormalities (Abnormal Baseline)
Assessment method [16] 0 0
Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes \< 0.8\* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes \<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; activated partial thromboplastin time, prothrombin time \>1.1\*ULN; bilirubin\>1.5\*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; creatine kinase \>2.0\*ULN.
Timepoint [16] 0 0
Baseline (Day 1, before dosing) up to Week 48
Secondary outcome [17] 0 0
Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period
Assessment method [17] 0 0
Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change \<=-40, change \>-40 to -30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30, change \>=30 to \<40 and change \>=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change \<=-30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30 and change \>=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below.
Timepoint [17] 0 0
Baseline (Day 1, before dosing) up to Week 24
Secondary outcome [18] 0 0
Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data
Assessment method [18] 0 0
Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450\<=Value\<480 millisecond (msec), 480\<=Value\<500 msec and Value\>=500 msec.
Timepoint [18] 0 0
Baseline (Day 1, before dosing) up to Week 24
Secondary outcome [19] 0 0
Number of Participants With Confirmed Orthostatic Hypotension
Assessment method [19] 0 0
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (\<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP \>=20 mmHg or reduction in diastolic BP \>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (\>) 150 mmHg (mean supine): reduction in systolic BP \>=30 mmHg or reduction in diastolic BP \>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Timepoint [19] 0 0
Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48
Secondary outcome [20] 0 0
Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE
Assessment method [20] 0 0
The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure.
Timepoint [20] 0 0
Day 1 of dosing up to maximum of Week 48
Secondary outcome [21] 0 0
Number of Participants With Abnormal Physical Examination at Screening
Assessment method [21] 0 0
Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations.
Timepoint [21] 0 0
Screening (up to 37 days prior to Day 1)
Secondary outcome [22] 0 0
Number of Participants With Individual Adjudicated Joint Safety Outcome/Event
Assessment method [22] 0 0
Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome.
Timepoint [22] 0 0
During the study, maximum up to Week 48
Secondary outcome [23] 0 0
Number of Participants With At Least 1 Total Joint Replacements (TJR)
Assessment method [23] 0 0
Number of participants with joint replacement surgery were reported.
Timepoint [23] 0 0
During the study, maximum up to Week 48
Secondary outcome [24] 0 0
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb)
Assessment method [24] 0 0
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported.
Timepoint [24] 0 0
Baseline (Day 1, before dosing) up to Week 48

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pain related to an oncologic emergency.
* Brain metastasis or leptomeningeal metastasis.
* Presence of hypercalcemia at Screening.
* Pain primarily classified as not predominantly related to a bone metastasis.
* Systemic treatment for the primary malignancy or bone metastasis started within 30 days of the Baseline Assessment Period.
* Chemotherapies associated with peripheral neuropathy (ie, paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide or bortezomib) are prohibited during the study from 30 days prior to the first day of the Baseline Assessment Period to Week 48.
* Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 30 days of the Baseline Assessment Period.
* Concurrent adjuvant analgesics unless started at least 30 days prior to the start of the Baseline Assessment Period and maintained at a stable dose.
* Diagnosis of osteoarthritis of the knee or hip or findings consistent with osteoarthritis in the shoulder.
* History of significant trauma or surgery to a major joint within one year prior to Screening.
* History of osteonecrosis or osteoporotic fracture.
* X-ray evidence at Screening of: 1) rapidly progressive osteoarthritis, 2) atrophic or hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture.
* Signs and symptoms of clinically significant cardiac disease.
* Evidence of orthostatic hypotension at Screening or at Baseline prior to randomization.
* Diagnosis of a transient ischemic attack in the 6 months prior to Screening or diagnosis of stroke with significant residual deficits.
* History, diagnosis, or signs and symptoms of clinically significant neurological disease.
* Total impact score of >7 on the Survey of Autonomic Symptoms (SAS) at Screening.
* Past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening.
* History of significant alcohol, analgesic, or narcotic substance abuse within the six months prior to Screening.
* Planned surgical procedure during the duration of the study.
* Considered unfit for surgery or not willing to undergo joint replacement surgery if required.
* Known hypersensitivity to opioids or an underlying medical condition contraindicating opioid use.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
* Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor antibody.
* Presence of drugs of abuse, prescription medications without a valid prescription or other illegal drugs at Screening.
* Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests at Screening indicative of current infection.
* Investigational site staff members and their family members, or Pfizer employees directly involved in the conduct of the trial.
* Participation in other studies involving investigational drug(s) within 30 days (or 90 days for investigational biologics) before Baseline Assessment Period and/or during study participation.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use one (1) highly effective method of contraception throughout the study and for 112 days after last dose of investigational product.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/06/2021
Sample size
Target
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Monash Medical Centre - East Bentleigh
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Santa FE
Country [2] 0 0
Austria
State/province [2] 0 0
Krems
Country [3] 0 0
Austria
State/province [3] 0 0
Senftenberg
Country [4] 0 0
Brazil
State/province [4] 0 0
RIO Grande DO SUL
Country [5] 0 0
Brazil
State/province [5] 0 0
RJ
Country [6] 0 0
Brazil
State/province [6] 0 0
SAO Paulo
Country [7] 0 0
Brazil
State/province [7] 0 0
SC
Country [8] 0 0
Brazil
State/province [8] 0 0
SP
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Chile
State/province [10] 0 0
Araucania
Country [11] 0 0
China
State/province [11] 0 0
Anhui
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Chongqing
Country [14] 0 0
China
State/province [14] 0 0
Heilongjiang
Country [15] 0 0
China
State/province [15] 0 0
Henan
Country [16] 0 0
China
State/province [16] 0 0
Hubei
Country [17] 0 0
China
State/province [17] 0 0
Shanghai
Country [18] 0 0
China
State/province [18] 0 0
Sichuan
Country [19] 0 0
China
State/province [19] 0 0
Zhejiang
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
Czechia
State/province [21] 0 0
Plzen
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 2
Country [23] 0 0
Hungary
State/province [23] 0 0
Farkasgyepu
Country [24] 0 0
Hungary
State/province [24] 0 0
Miskolc
Country [25] 0 0
Hungary
State/province [25] 0 0
Nyiregyhaza
Country [26] 0 0
Hungary
State/province [26] 0 0
Szekesfehervar
Country [27] 0 0
Israel
State/province [27] 0 0
Afula
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
Country [29] 0 0
Israel
State/province [29] 0 0
Ramat Gan
Country [30] 0 0
Japan
State/province [30] 0 0
Aichi
Country [31] 0 0
Japan
State/province [31] 0 0
Chiba
Country [32] 0 0
Japan
State/province [32] 0 0
Gunma
Country [33] 0 0
Japan
State/province [33] 0 0
Hyogo
Country [34] 0 0
Japan
State/province [34] 0 0
Saga
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Gyeonggi-do
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Daegu
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Seoul
Country [39] 0 0
Poland
State/province [39] 0 0
Bedzin
Country [40] 0 0
Poland
State/province [40] 0 0
Bialystok
Country [41] 0 0
Poland
State/province [41] 0 0
Czeladz
Country [42] 0 0
Poland
State/province [42] 0 0
Dabrowa Gornicza
Country [43] 0 0
Poland
State/province [43] 0 0
Gdansk
Country [44] 0 0
Poland
State/province [44] 0 0
Gliwice
Country [45] 0 0
Poland
State/province [45] 0 0
Grudziadz
Country [46] 0 0
Poland
State/province [46] 0 0
Katowice
Country [47] 0 0
Poland
State/province [47] 0 0
Lublin
Country [48] 0 0
Poland
State/province [48] 0 0
Poznan
Country [49] 0 0
Poland
State/province [49] 0 0
Warszawa
Country [50] 0 0
Romania
State/province [50] 0 0
Dolj
Country [51] 0 0
Romania
State/province [51] 0 0
Timis
Country [52] 0 0
Romania
State/province [52] 0 0
Bucuresti
Country [53] 0 0
Slovakia
State/province [53] 0 0
Bratislava
Country [54] 0 0
Slovakia
State/province [54] 0 0
Nove Zamky
Country [55] 0 0
Slovakia
State/province [55] 0 0
Pruske
Country [56] 0 0
Slovakia
State/province [56] 0 0
Zilina
Country [57] 0 0
Spain
State/province [57] 0 0
Alicante
Country [58] 0 0
Spain
State/province [58] 0 0
Islas Baleares
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02609828