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

Phase 3 Completed 156 enrolled Pfizer Eli Lilly and Company · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2015-10-28
Primary completion: 2020-09-17
Completion: 2021-06-25

Outcome

Met primary endpoint

paper Tanezumab 20 mg met the primary efficacy endpoint at week 8. PMID 37343145 ↗

registry Placebo vs Tanezumab 20 mg; p = 0.0381; Differences in least square (LS) mean -0.78 (95% CI -1.52 to -0.04) NCT02609828 ↗

release “Study A4091061 (NCT02609828) met its primary endpoint of demonstrating a statistically significant improvement in daily average pain intensity at eight weeks” lilly.com ↗

Publications

Fallon M, Sopata M, Dragon E, Brown MT, Viktrup L, West CR, Bao W, Agyemang A. A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis. Oncologist. 2023 Dec 11;28(12):e1268-e1278. doi: 10.1093/oncolo/oyad188.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tanezumab	Monoclonal antibody	20 mg	Subcutaneous