Phase II Multicenter Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 19
- 主要终点
- Progression free survival (PFS) rate
研究概览
简要总结
Non-randomized, open, two-cohort, phase II, multicenter national clinical trial. 20 sites in Spain.
Cohort 1 includes soft-tissue sarcoma and osteosarcoma (21 patients), while Cohort 2 includes chordoma patients only (19 patients).
Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days. Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.
The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1 at 6 months.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Palbocilib
Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days.
干预措施: Palbociclib (Drug)
结局指标
主要结局
Progression free survival (PFS) rate
时间窗: At 6 months
Efficacy measured through the progression free survival (PFS) rate at 6 months, evaluated with RECIST 1.1 criteria.
次要结局
- Efficacy measured through median PFS(6 months)
- Overall response rate (ORR)(6 months)
- Efficacy measured through response according to Choi criteria measured through response according to Choi criteria:(6 months)
- Overall survival (OS)(2 years)
- Clinical Benefit Rate (CBR)(6 months)
- Palbociclib safety profile(1 year)
- Efficacy measured through PFS rate at 3 months(3 months)