Phase 2 N=59 Randomized Quadruple-blind Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT00545129 ↗

Enrolled (actual)

Serious AEs

18.6%

Results posted

Jun 2021

Primary outcome: 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 units on a scale — p=0.569

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tanezumab 10 mg IV (Drug); IV Placebo for tanezumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2011

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.