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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00104650
First received: March 3, 2005
Last updated: January 20, 2011
Last verified: January 2011
  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 2

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.


Secondary Outcome Measures:
  • uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25 [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.

  • Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25 [ Time Frame: Baseline, week 25 ] [ Designated as safety issue: No ]
    Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.

  • Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.

  • Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]
    Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.

  • Percent Change of Serum CTX From Baseline to Week 25 [ Time Frame: Baseline, week 25 ] [ Designated as safety issue: No ]
    Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.

  • Time to First Skeletal Related Event [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]
    Time from study day 1 to first Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

  • Skeletal Related Events [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]
    Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

  • Hypercalcemia [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: Yes ]
    Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria


Enrollment: 111
Study Start Date: January 2005
Study Completion Date: March 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV Bisphosphonates q 4 weeks
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.
Experimental: 180 mg AMG 162 (SC) q 12 weeks
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.
Experimental: 180 mg AMG 162 (SC) q 4 weeks
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
  • Eastern Cooperative Oncology Group (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00104650     History of Changes
Obsolete Identifiers: NCT00121342
Other Study ID Numbers: 20040114
Study First Received: March 3, 2005
Results First Received: December 9, 2010
Last Updated: January 20, 2011
Health Authority: 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
Belgium: Pharmaceutical Inspectorate

Keywords provided by Amgen:
Bone Metastases
AMG 162
Bisphosphonates
Solid Tumor Carcinomas
Advanced

Additional relevant MeSH terms:
Breast Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases

ClinicalTrials.gov processed this record on August 28, 2014