drugset / Trial / NCT00104650
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
Timeline
- Start
- 2005-01
- Primary completion
- 2008-01
- Completion
- 2010-03
Publications
- Results Fizazi K, Lipton A, Mariette X, Body JJ, Rahim Y, Gralow JR, Gao G, Wu L, Sohn W, Jun S. Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates. J Clin Oncol. 2009 Apr 1;27(10):1564-71. doi: 10.1200/JCO.2008.19.2146. Epub 2009 Feb 23.
- Results Fizazi K, Bosserman L, Gao G, Skacel T, Markus R. Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial. J Urol. 2009 Aug;182(2):509-15; discussion 515-6. doi: 10.1016/j.juro.2009.04.023. Epub 2009 Jun 13.
- Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.
- Fizazi K, Bosserman L, Gao G, Skacel T, Markus R. Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial. J Urol. 2013 Jan;189(1 Suppl):S51-7; discussion S57-8. doi: 10.1016/j.juro.2012.11.022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 180 mg | Subcutaneous |
| Subject | Pamidronate | Small molecule | — | Intravenous |
| Subject | Zoledronic acid | Other / unclassified | — | Intravenous |