IRB #: 090898
Study Title: “A4091003 – A Phase II Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Study of Tanezumab As Add-On Therapy to Opioid Medication in Patients with Pain Due to Bone Metastases”
Dr. Mark Wallace and his associates are conducting a research study for Pfizer, Inc. to evaluate the safety and effectiveness of the investigational drug Tanezumab, for moderate to severe pain in adult cancer patients with bone metastases. This 16 week study seeks to observe the difference, if any, between patients who receive Tanezumab with their prescription pain medication(s), compared to patients receiving only their prescription pain medication(s). “Investigational” means that the study drug (Tanezumab), is currently being tested and has not received approval by the U.S. Food and Drug Administration (FDA) or Non-U.S. Regulatory Authorities.
After 8 weeks of this study, patients will be given the option of enrolling into the 40 week open label safety extension. Open Label means that all patients entering the extension phase will receive the Investigational Drug, Tanezumab.
Subjects will be eligible to participate in the clinical trial if they meet the following Inclusion Criteria:
- Must have prostate cancer, breast cancer, renal cell cancer or multiple myeloma that has been diagnosed as having metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis.
- The patient is expected to require daily opioid medication throughout the course of the study.
- Must be ≥18 years of age.
- Life expectancy of ≥6 months at Screening Visit.
Subjects will not be eligible to participate in the clinical trial if they meet any of the following Exclusion Criteria:
- The patient is about to begin or has begun systemic therapy for the primary malignancy (eg, chemotherapy) within 2 weeks of randomization, or for a bone metastasis (e.g., bisphosphonates) within 4 weeks of randomization.
- Currently receiving therapy for the primary malignancy (e.g., chemotherapy) which began more than 2 weeks before randomization or for a bone metastasis (e.g., bisphosphonates), which began more than 4 weeks before randomization and is anticipated to change (including additions to or changes in chemotherapy regimen) during the treatment period, unless the investigator determines the therapy is unlikely to improve pain. Completion of non-changing, ongoing therapy begun more than 4 weeks before randomization is allowed..
- Planned surgical procedure during the duration of the study.
- Use of other drugs to control pain, such as non-steroidal anti-inflammatory drugs (NSAIDs, including selective Cox-2 inhibitors), SNRIs, tricyclic antidepressants, anticonvulsant medication, corticosteroids, or muscle relaxants unless these drugs were started more than 30 days prior to randomization and unless they are maintained at a stable dose.
- Positive Hepatitis B, Hepatitis C, or HIV tests at screening, indicative of current or past infection.
Cindy Martin, Clinical Research Coordinator
Staff Research Associate III
University of California, San Diego Medical Center
Center for Pain Medicine
Tel. 858-657-7038 ext.77038