NCT00104650 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2011-01-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Percent Change of Serum CTX From Baseline to Week 25

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outcome · POSTED

Time to First Skeletal Related Event

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outcome · POSTED

Skeletal Related Events

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outcome · POSTED

Hypercalcemia

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: IV Bisphosphonate q 4 weeks
label
IV Bisphosphonates q 4 weeks
type
ACTIVE_COMPARATOR
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.
intervention Names
Genetic: AMG 162 180 mg (SC) q 12 weeks
label
180 mg AMG 162 (SC) q 12 weeks
type
EXPERIMENTAL
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 Names
Genetic: AMG 162- 180 mg q 4 weeks
label
180 mg AMG 162 (SC) q 4 weeks
type
EXPERIMENTAL

interventions

arm Group Labels
180 mg AMG 162 (SC) q 12 weeks
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.
name
AMG 162 180 mg (SC) q 12 weeks
type
GENETIC
arm Group Labels
IV Bisphosphonates q 4 weeks
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.
name
IV Bisphosphonate q 4 weeks
type
DRUG
arm Group Labels
180 mg AMG 162 (SC) q 4 weeks
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.
name
AMG 162- 180 mg q 4 weeks
type
GENETIC

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 111
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.
measure
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13
time Frame
13 weeks

secondary Outcomes

description
Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.
measure
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25
time Frame
25 weeks
description
Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.
measure
Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25
time Frame
Baseline, week 25
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.
measure
Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol
time Frame
Day 1, week 25
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.
measure
Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol
time Frame
Day 1, 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.
measure
Percent Change of Serum CTX From Baseline to Week 25
time Frame
Baseline, week 25
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).
measure
Time to First Skeletal Related Event
time Frame
Day 1, week 25
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).
measure
Skeletal Related Events
time Frame
Day 1, week 25
description
Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria
measure
Hypercalcemia
time Frame
Day 1, week 25

Full 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.

Source references

references

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.
pmid
19237632
type
RESULT
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.
pmid
19524963
type
RESULT
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.
pmid
33270906
type
DERIVED
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.
pmid
23234632
type
DERIVED