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Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Metastases; Bone Metastases in Subjects With Advanced Breast Cancer

Intervention: Denosumab (Biological); IV Bisphosphonates (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

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

Clinical Details

Official title: A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)

Secondary outcome:

Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)

Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13

Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25

Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline

Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)

Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)

Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)

Percent Change From Baseline to Week 25 in P1NP

Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)

Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)

Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)

Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)

Percent Change From Baseline to Week 13 in Osteocalcin

Percent Change From Baseline to Week 25 in Osteocalcin

Time to First Skeletal Related Event

Number of Participants With Skeletal Related Events

Number of Participants With Hypercalcemia

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma

- At least one bone metastasis

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

Related publications:

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. Epub 2007 Sep 4.

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;

Starting date: September 2004
Last updated: December 20, 2013

Page last updated: August 23, 2015

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