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

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00104650

Purpose

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.

Condition	Intervention	Phase
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	Genetic: AMG 162 180 mg (SC) q 12 weeks Drug: IV Bisphosphonate q 4 weeks Genetic: AMG 162- 180 mg q 4 weeks	Phase II

Genetics Home Reference related topics: aceruloplasminemia breast cancer hemophilia

MedlinePlus related topics: Breast Cancer Cancer Multiple Myeloma Prostate Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates

Further study details as provided by Amgen:

Primary Outcome Measures:

Proportion of subjects with urinary N-Telopeptide less than 50 nM BCE / mM creatinine at week 13 [ Time Frame: Within 13 weeks of the treatment phase after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects achieving urinary N-Telopeptide levels less than 50 nM BCE / mM creatinine during the course of the study [ Time Frame: During the course of this study ] [ Designated as safety issue: No ]
Time to reduction of urinary N-Telopeptide to less than 50 nM BCE/ mM creatinine [ Time Frame: During the course of this study ] [ Designated as safety issue: No ]
Duration of urinary N-Telopeptide (uNTx) level less than 50 nM BCE / mM creatinine [ Time Frame: During the couse of this study ] [ Designated as safety issue: No ]
Percent change of C-Telopeptide (sCTx) from baseline to week 25 [ Time Frame: Within 25 weeks of the treatment phase after randomization ] [ Designated as safety issue: No ]
Percent change of urinary N-Telopeptide (uNTx) from baseline to week 25 [ Time Frame: 25-week treatment plus 105-week extension and 32-week safety follow up ] [ Designated as safety issue: No ]
Proportion of study subjects experiencing skeletal related events (SRE) and the time to first on study SRE. SRE will be defined as bone fracture, including vertebral fracture; surgery or radiation therapy to bone; spinal cord compression [ Time Frame: 2Within 25 weeks of the treatment phase after randomization ] [ Designated as safety issue: No ]
Incidence of hypercalcemia [ Time Frame: During the course of this study ] [ Designated as safety issue: No ]

Estimated Enrollment:	135
Study Start Date:	January 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.
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 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 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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
ECOG 0, 1 or 2

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104650

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040114
Study First Received:	March 3, 2005
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00104650 History of Changes
Health Authority:	Belgium: Pharmaceutical Inspectorate; Canada: Health Canada; European Union: European Medicines Agency; France: Ministry of Health; Mexico: Ministry of Health; Poland: Drug Institut; United States: Food and Drug Administration; United States: Western Institutional Review Board

Keywords provided by Amgen:

Bone Metastases
AMG 162
Bisphosphonates
Solid Tumor Carcinomas
Advanced

Study placed in the following topic categories:

Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Blood Protein Disorders
Bone Density Conservation Agents
Paraproteinemias
Urogenital Neoplasms
Hemostatic Disorders
Bone Diseases
Hemorrhagic Disorders
Musculoskeletal Diseases
Neoplasm Metastasis
Pamidronate
Breast Diseases
Zoledronic acid

Immunoproliferative Disorders
Skin Diseases
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Breast Neoplasms
Genital Diseases, Male
Carcinoma
Multiple Myeloma
Diphosphonates
Bone Marrow Diseases
Lymphoproliferative Disorders
Prostatic Neoplasms
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Prostatic Diseases
Bone Neoplasms
Genital Neoplasms, Male
Blood Protein Disorders
Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms
Paraproteinemias
Hemostatic Disorders
Bone Diseases
Neoplastic Processes
Neoplasms by Site
Hemorrhagic Disorders
Pathologic Processes
Musculoskeletal Diseases

Neoplasm Metastasis
Cardiovascular Diseases
Breast Diseases
Neoplasms by Histologic Type
Immunoproliferative Disorders
Skin Diseases
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Breast Neoplasms
Genital Diseases, Male
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Diphosphonates

ClinicalTrials.gov processed this record on May 07, 2009