Phase 3
Completed N=156
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
Bone Metastasis · Cancer Pain
Source: ClinicalTrials.gov NCT02609828 ↗
Enrolled (actual)
156
Serious AEs
80.0%
Results posted
Jan 2023
Primary outcomePrimary: Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 — -1.25; NA; NA; -2.03 Units on a scale — p=0.0381
◆ Published Evidence
Established
46citations · ~15 / year
A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis.
Summary
The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.
Linked Publications
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A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 |
-1.25; NA; NA; -2.03 | 0.0381 sig |
| SECONDARY 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 |
-0.40; NA; NA; -0.76; -0.72; NA | 0.0497 sig |
| SECONDARY 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 |
-0.52; NA; NA; -0.84; -0.74; NA | 0.1103 |
| SECONDARY 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 |
-0.64; NA; NA; -1.14; -0.96; NA | 0.3003 |
| SECONDARY 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 |
-0.43; NA; NA; -1.50; -0.34; NA | 0.0575 |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
8; 2; 0; 9; 4; 0 | 0.8054 |
| SECONDARY 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 |
7; 2; 0; 9; 1; 0 | 0.6658 |
| SECONDARY Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 |
-0.39; NA; NA; -0.43; -0.36; NA | 0.7045 |
| SECONDARY Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 |
7; 2; 0; 5; 9; 1 | 0.2033 |
| SECONDARY Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
183.94; NA; NA; 186.86; 177.98; NA | — |
| SECONDARY Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
1.15; NA; NA; 0.96; 1.11; NA | — |
| SECONDARY Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 |
-0.06; NA; NA; -0.11; -0.18; NA | 0.8069 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
52; 9; 1; 62 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Normal Baseline) |
18; 1; 20 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Abnormal Baseline) |
15; 2; 14 | — |
| SECONDARY Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period |
1; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data |
2; 1; 6; 0; 0; 1 | — |
| SECONDARY Number of Participants With Confirmed Orthostatic Hypotension |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE |
2; 0; 0; 2 | — |
| SECONDARY Number of Participants With Abnormal Physical Examination at Screening |
3; 1; 0; 6; 2; 1 | — |
| SECONDARY Number of Participants With Individual Adjudicated Joint Safety Outcome/Event |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With At Least 1 Total Joint Replacements (TJR) |
0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) |
0; 0; 0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Personally signed and dated informed consent document.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Male or female, ≥18 years of age
- Weight ≥40 kg at Screening
- Cancer diagnosed as having metastasized to bone or multiple myeloma.
- Imaging confirmation of bone metastasis at Screening or within 120 days prior to the Screening visit.
- Expected to require daily opioid medication throughout the course of the study.
- Willing to not use prohibited medications (including NSAIDs) throughout the duration of the study.
- Average Pain Score ≥5 at Screening for the index bone metastasis cancer pain site.
- Patient's Global Assessment of Cancer Pain of "fair", "poor" or "very poor" at Screening.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 at Screening.
- Adequate bone marrow, renal and liver function at Screening.
- International Normalized Ratio (INR) or prothrombin time (PT) 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.
Data sourced from ClinicalTrials.gov (NCT02609828) and the linked publication. 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.