Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

NCT00104650 | Completed Phase 2 Results

• 1 other identifier: 20040114
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer; Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Keywords

Bone Metastases; AMG 162; Bisphosphonates; Solid Tumor Carcinomas; Advanced

Outcome Measures

Primary Outcomes (1)

• uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13

  Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.

  13 weeks

Secondary Outcomes (8)

• uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25

  25 weeks

• Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25

  Baseline, week 25

• Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol

  Day 1, week 25

• Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol

  Day 1, week 25

• Percent Change of Serum CTX From Baseline to Week 25

  Baseline, week 25

Study Arms (3)

IV Bisphosphonates q 4 weeks

ACTIVE COMPARATOR

This is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks.

Drug: IV Bisphosphonate q 4 weeks

180 mg AMG 162 (SC) q 12 weeks

EXPERIMENTAL

This is an open-label randomization to receive 180 mg AMG 162 (SC) every 12 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 12 weeks.

Genetic: AMG 162 180 mg (SC) q 12 weeks

180 mg AMG 162 (SC) q 4 weeks

EXPERIMENTAL

This is an open-label randomization to receive 180 mg AMG 162 (SC) every 4 weeks during the treatment phase. If subject is enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 4 weeks.

Genetic: AMG 162- 180 mg q 4 weeks

Interventions

AMG 162 180 mg (SC) q 12 weeks GENETIC

A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.

180 mg AMG 162 (SC) q 12 weeks

IV Bisphosphonate q 4 weeks DRUG

IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.

IV Bisphosphonates q 4 weeks

AMG 162- 180 mg q 4 weeks GENETIC

A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.

180 mg AMG 162 (SC) q 4 weeks

Eligibility Criteria

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

You may qualify if:

• Patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma
• Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma
• Currently receiving IV bisphosphonates
• Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine
• Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

You may not qualify if:

• More than 2 prior skeletal related events (SRE)
• Known brain metastases
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
• Active dental or jaw conditions which requires oral surgery
• Non-healed dental/oral surgery
• Prior administration of AMG 162
• Evidence of impending fracture in weight bearing bones
• Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the study.

Sponsors & Collaborators

• Amgen: lead

Related Publications (4)

• 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.

  PMID: 19237632 RESULT

• 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.

  PMID: 19524963 RESULT

• 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.

  PMID: 33270906 DERIVED

• 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.

  PMID: 23234632 DERIVED

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Denosumab; Amelogenin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dental Enamel Proteins

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2010
• Last Updated: January 24, 2011
• Results First Posted: January 7, 2011

Record last verified: 2011-01