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Study Complete
Sponsor ID
20040114

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

Sponsor ID
20040114
Clinicaltrials.gov ID
NCT00104650
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
111
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 13 weeks

Secondary Outcome Measures

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

Timeframe: 25 weeks

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

Timeframe: Baseline, week 25

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

Timeframe: Day 1, week 25

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

Timeframe: Day 1, week 25

Percent Change of Serum CTX from Baseline to Week 25

Timeframe: Baseline, week 25

Time to First Skeletal Related Event

Timeframe: Day 1, week 25

Skeletal Related Events

Timeframe: Day 1, week 25

Hypercalcemia

Timeframe: Day 1, week 25

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Prostate Cancer
    • Show more
  • Breast Cancer
  • Multiple Myeloma
    • Sex
    All
    Trial Dates
    Jan 2005 - Jan 2008
    Inclusion and Exclusion 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.