Sponsor study identifier
interventional
255
0 countries
N/A
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2005
Actual (reported)Study Completion
October 2006
Actual (reported)This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 17, 2004
Actual (reported)September 21, 2004
Actual (reported)November 2005
Actual (reported)October 2006
Actual (reported)January 7, 2011
Actual (reported)Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.
Baseline and Week 13
Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)
Baseline and Week 25
Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13
Baseline and Week 13
Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25
Baseline and Week 25
Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline
Baseline to Week 57
Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)
Baseline and week 13
Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Denosumab administered by subcutaneous injection
Contact the study team to confirm eligibility.
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.
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.
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.
MD
Amgen
255 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2004
First Posted
September 21, 2004
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)
Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.
Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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;
Primary Completion
November 2005
Actual (reported)Study Completion
October 2006
Actual (reported)Last Updated
January 28, 2014
Results First Posted
January 7, 2011
Record last verified: 2013-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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