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

Amgen111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

111

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

Interventions

AMG 162 180 mg (SC) q 12 weeksGENETIC

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.

IV Bisphosphonate q 4 weeksDRUG

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.

AMG 162- 180 mg q 4 weeksGENETIC

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 13 weeks

Secondary Outcomes

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

Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.

Time frame: 25 weeks

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 frame: Baseline, week 25

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.

Time frame: Day 1, 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.

Time frame: Day 1, 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.

Data from ClinicalTrials.gov

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