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

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 theScreening visit.
• Expected to require daily opioid medication throughout the course of the study.
• Willing to not use prohibited medications (including NSAIDs) throughout the durationof 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" atScreening.
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 atScreening.
• Adequate bone marrow, renal and liver function at Screening.
• International Normalized Ratio (INR) or prothrombin time (PT) <1.5 x ULN at Screeningunless being treated with anticoagulant medication.
• Females must either be not of childbearing potential or, if of childbearing potentialand at risk for pregnancy, must be willing to use at least one highly effective methodof contraception throughout the study and for 112 days (16 weeks) after the last doseof assigned subcutaneous study medication.

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 30days of the Baseline Assessment Period.
• Chemotherapies associated with peripheral neuropathy (ie, paclitaxel, docetaxel,oxaliplatin, cisplatin, vincristine, thalidomide or bortezomib) are prohibited duringthe study from 30 days prior to the first day of the Baseline Assessment Period toWeek 48.
• Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bonemetastasis within 30 days of the Baseline Assessment Period.
• Concurrent adjuvant analgesics unless started at least 30 days prior to the start ofthe Baseline Assessment Period and maintained at a stable dose.
• Diagnosis of osteoarthritis of the knee or hip or findings consistent withosteoarthritis in the shoulder.
• History of significant trauma or surgery to a major joint within one year prior toScreening.
• History of osteonecrosis or osteoporotic fracture.
• X-ray evidence at Screening of: 1) rapidly progressive osteoarthritis, 2) atrophic orhypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneousosteonecrosis 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 torandomization.
• Diagnosis of a transient ischemic attack in the 6 months prior to Screening ordiagnosis of stroke with significant residual deficits.
• History, diagnosis, or signs and symptoms of clinically significant neurologicaldisease.
• 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 oneyear prior to Screening.
• History of significant alcohol, analgesic, or narcotic substance abuse within the sixmonths prior to Screening.
• Planned surgical procedure during the duration of the study.
• Considered unfit for surgery or not willing to undergo joint replacement surgery ifrequired.
• Known hypersensitivity to opioids or an underlying medical condition contraindicatingopioid use.
• History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonalantibody or IgG-fusion protein.
• Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factorantibody.
• Presence of drugs of abuse, prescription medications without a valid prescription orother illegal drugs at Screening.
• Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests atScreening indicative of current infection.
• Investigational site staff members and their family members, or Pfizer employeesdirectly involved in the conduct of the trial.
• Participation in other studies involving investigational drug(s) within 30 days (or 90days for investigational biologics) before Baseline Assessment Period and/or duringstudy participation.
• Pregnant female subjects; breastfeeding female subjects; female subjects ofchildbearing potential who are unwilling or unable to use one (1) highly effectivemethod of contraception throughout the study and for 112 days after last dose ofinvestigational product.
• Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality.