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

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.