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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 162 180 mg (SC) q 12 weeks
IV Bisphosphonate q 4 weeks
AMG 162- 180 mg q 4 weeks
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases in Men With Hormone-Refractory Prostate Cancer focused on measuring Bone Metastases, AMG 162, Bisphosphonates, Solid Tumor Carcinomas, Advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    IV Bisphosphonates q 4 weeks

    180 mg AMG 162 (SC) q 12 weeks

    180 mg AMG 162 (SC) q 4 weeks

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25
    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
    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
    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 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
    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 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
    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
    Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria

    Full Information

    First Posted
    March 3, 2005
    Last Updated
    January 20, 2011
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00104650
    Brief Title
    Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
    Official Title
    A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    111 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IV Bisphosphonates q 4 weeks
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    180 mg AMG 162 (SC) q 12 weeks
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    180 mg AMG 162 (SC) q 4 weeks
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Genetic
    Intervention Name(s)
    AMG 162 180 mg (SC) q 12 weeks
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    IV Bisphosphonate q 4 weeks
    Intervention Description
    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.
    Intervention Type
    Genetic
    Intervention Name(s)
    AMG 162- 180 mg q 4 weeks
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13
    Description
    Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.
    Time Frame
    13 weeks
    Secondary Outcome Measure Information:
    Title
    uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25
    Description
    Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.
    Time Frame
    25 weeks
    Title
    Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25
    Description
    Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.
    Time Frame
    Baseline, week 25
    Title
    Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol
    Description
    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.
    Time Frame
    Day 1, week 25
    Title
    Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol
    Description
    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.
    Time Frame
    Day 1, week 25
    Title
    Percent Change of Serum CTX From Baseline to Week 25
    Description
    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 Frame
    Baseline, week 25
    Title
    Time to First Skeletal Related Event
    Description
    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).
    Time Frame
    Day 1, week 25
    Title
    Skeletal Related Events
    Description
    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).
    Time Frame
    Day 1, week 25
    Title
    Hypercalcemia
    Description
    Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria
    Time Frame
    Day 1, week 25

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19237632
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19524963
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    33270906
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    23234632
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results

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

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