NCT00538239已完成3 期
A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 711
- 主要终点
- Progression-free Survival
研究概览
简要总结
The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Confirmed diagnosis of metastatic soft-tissue or bone sarcoma
- •Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Adequate organ and bone marrow function
- •Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
排除标准
- •Prior therapy with rapamycin or rapamycin analogs
- •Ongoing toxicity associated with prior anticancer therapy
- •Another primary malignancy within the past three years
- •Concomitant medications that induce or inhibit CYP3A
- •Significant, uncontrolled cardiovascular disease
研究组 & 干预措施
Ridaforolimus
Experimental
干预措施: ridaforolimus (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Up to 157 weeks after randomization
次要结局
- Overall survival: First Analysis(Up to 157 weeks after randomization)
- Best Target Lesion Response (RECIST)(Up to 157 weeks after randomization)
- Overall Survival: Updated Analysis as of 30 April 2011(Up to 184 weeks after randomization)
- Overall Survival: Updated Analysis as of 21 January 2012(Up to 222 weeks after randomization)
- Safety and tolerability(Up to 157 weeks after randomization)
研究者
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