A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

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.

Timeline

Start

2009-04-29

Primary completion

2011-12-24

Completion

2012-02-07

Outcome

Missed primary endpoint

paper At the primary endpoint of study 1003, least squares mean (SE) difference in change from baseline in daily average pain vs placebo was -0.26 (0.45; P = 0.569). PMID 25919474 ↗

paper Although the primary endpoint was not achieved, tanezumab may provide additional sustained analgesia in patients with metastatic bone pain taking daily opioids. PMID 25919474 ↗

Publications

• Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211.
• Bapat AA, Hostetter G, Von Hoff DD, Han H. Perineural invasion and associated pain in pancreatic cancer. Nat Rev Cancer. 2011 Sep 23;11(10):695-707. doi: 10.1038/nrc3131.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tanezumab	Monoclonal antibody	10 mg	Intravenous

Indications