Bone metastases of breast cancer
Conditions
Interventions
Human Monoclonal Antibody to RANKL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
Trade Name: Zometa
Product Name: zoledronic acid
Pharmaceutic
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed breast adenocarcinomas Radiographic evidence of at least 1 bone metastases Female at least 18 years old ECOG SCORE (0, 1, or 2) Adequate organ function as defined as follows: - serum aspartate aminotransferase (AST: serum glutamate-oxalate transferase (SGOT) and serum alanine aminotransferase (ALT; SGPT) less than or equal to 2.5 times the ULN - if liver function abnormalities are due to the underlying malignancy, then AST and ALT must be less than 5 times the ULN - total serum bilirubin is less than or equal to 1.5 times the ULN - absolute neutrophil count (ANC) is greater or equal to 1.5 times 10*9/L - platelets is greater or equal to 100 times 10*9 /L - hemoglobin is greater or equal to 9.0 g/dL - albumin-adjusted serum calcium is greater 2 times ULN - serum creatinine is less than or equal to 2.0 times ULN Concurrent chemotherapy or hormonal therapy for metastatic breast cancer is allowed during study treatment if no changes in regimens or agents are planned during the first 3 months on study Prior oral bisphosphonate use must meet one of the following conditions: -No prior oral bisphosphonate use OR -Total cumulative oral bisphosphonate use of = 8 weeks and no oral bisphosphonate use in the 2 weeks before randomization OR -Total cumulative oral bisphosphonate use of > 8 weeks and no oral bisphosphonate use in the 24 weeks before randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unresolved toxicities greater than grade 2 from prior anti-cancer therapy, excluding apocepia Presence of untreated or symptomatic brain metastases Current or prior (IV or oral) bisphosphonate administration Administration of OPG construct ( ie AMGN-007, Fc-OPG or AMG 162) Administration of calcitonin, PTH, mithramycin, strontium rannelate, gallium nitrate within 8 weeks prior to randomisation Current therapy with chronic systemic corticosteroid administration (> 5 mg/day of prednisone or equivalent daily), unless the corticosteroids are administered as part of antineoplastic treatment Evidence of impending fracture in weight bearing bones Radiation therapy to bone within 2 weeks before randomisation Treatment with radioisotopes detected to bone within 8 weeks before randomisation Evidence of any of the following conditions: - current hyper or hypothyroidism - Pagets disease, hyperprolactinemia or chronic liver disease - Prior malignancy - unstable systemic diseases includinh active infection, incontrolled hypertension, unstable angina, congestive heart failure or myocardial infection within 6 months of randomisation - major surgery, or significant traumatic injury occuring within 4 weeks before randomisation. - known HIV infection Any organic or psychiatric disorder, serum chemistry, or hematology, which in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results Currently enrolled in or less than 30 days since receipt of any investigational drug or device (administered/used as part of an investigational study) that is not approved by the applicable regulatory authority Pregnancy or breastfeeding. Subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All subjects with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days before randomization. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate Known sensitivity to any of the products to be administered during dosing (ie, bisphosphonates or mammalian derived products) Any kind of disorder that compromises subject’s ability to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of different doses and schedules of AMG 162 on the percent change from baseline in urinary N-telopeptide (uNTx) at week 13;Secondary Objective: To characterise the safety profile of AMG 162 administered subcutaneously (SC) at 30 mg, 120 mg, or 180 mg every q4 weeks or 60 mg or 180 mg every q 12 weeks To evaluate the pharmacokinetic parameters of AMG 162 at different doses and schedules;Primary end point(s): The primary efficacy endpoint is the percentage change from baseline to week 13 in uNTx. This change is defined as (wk 13 uNTx- baseline uNTx) Baseline uNTx | — |
Countries
Austria, Italy, Spain, United Kingdom
Outcome results
None listed