Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

Summary

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Timeline

Start

2004-09

Primary completion

2005-11

Completion

2006-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Bisphosphonate IV Q4W vs Denosumab 30 mg Q4W vs Denosumab 120 mg Q4W vs Denosumab 180 mg Q4W vs Denosumab 60 mg Q12W vs Denosumab 180 mg Q12W; p = 0.245; ANCOVA NCT00091832 ↗

Publications

• Background Campbell-Baird C, Lipton A, Sarkenshik M, Ma H, Jun S.Incidence of Acute Phase Events Following Denosumab or Intravenous Bisphosphonates: Results From a Randomized, Controlled Phase 2 Study in Patients With Breast Cancer and Bone Metastases.Journal-001752;2010;7:85-89.
• Background Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman RE, Paterson AH, Gao GM, Kinsey AC, Peterson MC, Jun S. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res. 2008 Oct 15;14(20):6690-6. doi: 10.1158/1078-0432.CCR-07-5234.
• Background Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman R, Paterson AH, Peterson MC, Fan M, Kinsey A, Jun S. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol. 2007 Oct 1;25(28):4431-7. doi: 10.1200/JCO.2007.11.8604. Epub 2007 Sep 4.
• Background Peterson M, Rodriquez R., Gurrola E., Sohn W, Jun S (others??).Population pharmacokinetics and pharmacodynamics of denosumab in breast cancer patients with bone metastases.Journal-000709;

Drugs

Indications