Phase 2
Completed N=59
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
Neoplasm Metastasis · Palliative Care
Source: ClinicalTrials.gov NCT00545129 ↗
Enrolled (actual)
59
Serious AEs
18.6%
Results posted
Jun 2021
Primary outcomePrimary: Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6 — 5.4; 5.3; -1.3; -0.9 units on a scale — p=0.569
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6 |
5.4; 5.3; -1.3; -0.9 | 0.569 |
| SECONDARY Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 |
-0.8; -0.6; -0.9; -0.8; -1.3; -1.2 | 0.581 |
| SECONDARY 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) |
6.3; 6.4; -0.8; -0.6; -0.8; -1.0 | 0.299 |
| SECONDARY 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) |
6.3; 6.4; -0.8; -0.6; -0.8; -1.0 | 0.299 |
| SECONDARY 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 |
5.2; 5.1; -0.4; -0.4; -0.9; -0.8 | 0.906 |
| SECONDARY 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 |
5.2; 5.1; -0.6; -0.5; -1.0; -1.0 | 0.655 |
| SECONDARY 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 |
6.1; 6.0; -0.8; -0.4; -1.0; -1.0 | 0.445 |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF |
6.1; 6.0; -1.1; -0.5; -1.1; -1.3 | 0.179 |
| SECONDARY 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 |
10.3; 13.3; 3.4; 0.0; 0.0; 0.0 | 1.000 |
| SECONDARY 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 |
10.3; 13.3; 3.4; 0.0; 0.0; 0.0 | 1.000 |
| SECONDARY Average Daily Opioid Consumption |
112.8; 98.3; 111.8; 102.0; 111.9; 102.7 | — |
| SECONDARY Number of Doses of Rescue Medication Required Per Week |
9.5; 5.6; 9.0; 5.0; 8.9; 5.2 | 0.188 |
| SECONDARY Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 |
2.05; 2.33; 0.1; -0.3; -0.2; -0.2 | 0.215 |
| SECONDARY 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 |
4.90; 5.19; -0.3; -0.8; -0.9; -1.1 | 0.666 |
| SECONDARY 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 |
4.90; 5.19; -0.4; -0.9; -1.0; -1.5 | 0.897 |
| SECONDARY Patient's Global Evaluation of Study Medication |
2.7; 2.3; 2.6; 2.4; 2.4; 2.3 | 0.399 |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF |
3.26; 2.92; -0.3; 0.2; -0.4; 0.0 | 0.108 |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF |
3.26; 2.92; -0.3; 0.2; -0.4; -0.0 | 0.108 |
| SECONDARY Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF |
3.7; 3.8; 0; 3.8; 7.4; 3.8 | 0.724 |
| SECONDARY Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF |
3.7; 3.8; 0; 7.7; 7.4; 3.8 | 0.724 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
18; 18; 7; 4 | — |
| SECONDARY Number of Participants With Physical Examination Abnormalities |
2; 8 | — |
| SECONDARY Number of Participants With Abnormal Neurological Examination |
1; 3; 2; 3; 1; 5 | — |
| SECONDARY Vital Sign Examination: Body Temperature |
36.7; 36.6; 36.7; 36.6; 36.7; 36.6 | — |
| SECONDARY Vital Sign Examination: Blood Pressure (BP) |
125.4; 120.6; 121.9; 123.2; 121.4; 121.8 | — |
| SECONDARY Vital Sign Examination: Respiratory Rate |
15.5; 16.9; 16.0; 16.8; 15.6; 16.0 | — |
| SECONDARY Vital Sign Examination: Heart Rate |
82.1; 82.6; 80.4; 81.3; 78.5; 79.7 | — |
| SECONDARY Body Weight of Participants |
68.5; 72.6; 67.4; 74.3; 66.5; 76.0 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Examination |
27; 29 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies |
0; 1; 0; 0; 1 | — |
| SECONDARY Electrocardiogram Examination |
742.7; 767.7; 774.9; 792.5; 774.1; 777.2 | — |
| SECONDARY Electrocardiogram Examination: Heart Rate |
84.0; 81.1; 80.1; 78.5; 80.9; 80.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00545129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.