A randomised active controlled study of AMG 162 in breast cancer subjects with bone metastases who have not previously been treated with bisphosphonate therapy

Amgen Inc0 个研究点目标入组 240 人开始时间: 2004年9月16日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•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
•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

•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 system corticosteroid administration, equal to or greater than 5 mg/day prednisolone or equivalent daily
•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

发起方