EUCTR2006-002669-38-DK进行中（未招募）不适用
A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD) - Women with Breast Cancer and Established Metastatic Bone Disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Women with breast cancer and MBD
- •Postmenopausal or using adequate contraception
- •Stable chemotherapy or hormone therapy regimen
- •Recovered from radiotherapy or surgery
- •Urinary NTx > 50 nmol BCE/mmol creatinine
- •Performance status < 2.0 on the ECOG Performance Scale
- •Adequate organ function
- •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
- •Current bisphosphonate use or bisphosphonate use within the prior 3 m months
- •Investigational drugs within the prioir 4 weeks
- •CNS metastases or meningeal involvement or primary CNS tumor
- •Ascites or pleural effusion with significant symptoms
- •Other primary cancer
- •Other significant, concurrent disease
- •Psychiatric disorders or substance abuse
- •Breast feeding or expected to conceive
- •6)Patient has significant hypercalcemia (defined as serum calcium >2.7 mmol/L or >10.8 mg/dL).
- •7)Patient is known to be HIV positive or has an AIDS-related illness or has a known history of active hepatitis B or C.
- •8)Patient had a prior malignancy with the exceptions of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; or has undergone potentially curative therapy with no evidence of recurrence for 5 years and is deemed at low risk for recurrence by the treating physician.
- •9)The patient has a known clinical hypersensitivity to zoledronic acid, or other bisphosphonates.
- •10)The patient plans to undergo invasive dental procedures, such as dental surgery or tooth extraction, during the 6 weeks of the study.
研究者
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