NCT01010672已完成2 期
A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Progression free rate (PFR) at 6 months
研究概览
简要总结
The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
- •Adequate organ and bone marrow function
排除标准
- •Presence of brain or central nervous system (CNS) metastases, unless successfully treated
- •Prior therapy with rapamycin or rapamycin analogs
- •Ongoing toxicity associated with prior anticancer therapy
- •History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient
研究组 & 干预措施
Ridaforolimus 40 mg
Experimental
干预措施: Ridaforolimus (Drug)
结局指标
主要结局
Progression free rate (PFR) at 6 months
时间窗: 6 months
Progression free rate at 6 months is defined as the proportion of participants who are a complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions) or stable disease (does not qualify for PR or progressive disease) at 6 months from the date of the first study drug administration.
次要结局
未报告次要终点
研究者
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