Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

NCT00091832 | Completed Phase 2 Results

• 1 other identifier: 20040113
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer; Metastases; Bone Metastases in Subjects With Advanced Breast Cancer

Keywords

Breast Cancer; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• 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

Study Arms (6)

Denosumab 60 mg every 12 weeks

EXPERIMENTAL

Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.

Biological: Denosumab

Denosumab 120 mg every 4 weeks

EXPERIMENTAL

Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Biological: Denosumab

Denosumab 180 mg every 4 weeks

EXPERIMENTAL

Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Biological: Denosumab

IV bisphosphonates every 4 weeks

ACTIVE COMPARATOR

Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.

Drug: IV Bisphosphonates

Denosumab 180 mg every 12 weeks

EXPERIMENTAL

Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.

Biological: Denosumab

Denosumab 30 mg every 4 weeks

EXPERIMENTAL

Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Biological: Denosumab

Interventions

Denosumab BIOLOGICAL

Denosumab administered by subcutaneous injection

Also known as: AMG 162

Denosumab 120 mg every 4 weeks; Denosumab 180 mg every 12 weeks; Denosumab 180 mg every 4 weeks; Denosumab 30 mg every 4 weeks; Denosumab 60 mg every 12 weeks

IV Bisphosphonates DRUG

Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid

IV bisphosphonates every 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one bone metastasis

Sponsors & Collaborators

• Amgen: lead

Related Publications (4)

• 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.

  PMID: 18927312 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.

  PMID: 17785705 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;

  BACKGROUND

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Denosumab; Diphosphonates

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2004
• First Posted: September 21, 2004
• Study Start: September 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: October 1, 2006
• Last Updated: January 28, 2014
• Results First Posted: January 7, 2011

Record last verified: 2013-12