EUCTR2004-000509-24-GB进行中（未招募）1 期
A randomised active controlled study of AMG 162 in breast cancer subjects with bone metastases who have not previously been treated with bisphosphonate therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
- •-Total cumulative oral bisphosphonate use of = 8 weeks and no oral bisphosphonate use in the 2 weeks before randomization
- •-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
排除标准
- •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
研究者
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