NCT02343172已完成1 期
A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment.
研究概览
简要总结
To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy
- •Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment
- •ECOG performance status of 0-1
排除标准
- •Prior treatment with compounds with the same mode of action
- •Patients with TP53 mutated tumors, if the molecular status is known
- •Symptomatic central nervous system metastases
- •Inadequate organ function
- •Previous and concomitant therapy that precludes enrollment, as defined by protocol
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
HDM201+LEE011
Experimental
干预措施: HDM201 (Drug)
HDM201+LEE011
Experimental
干预措施: LEE011 (Drug)
结局指标
主要结局
Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment.
时间窗: 5 years
DLTs in the first cycle of treatment.
Phase Ib: Exposure to HDM201 and LEE011 as measured by AUC 0-24h
时间窗: 5 years
as measured by AUC0-24h
Phase II: Progression free survival (PFS)
时间窗: 5 years
To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma
次要结局
- Phase Ib/II: Incidence and severity of AEs and SAEs(5 years)
- Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: AUCtau(5 years)
- Phase Ib: BOR, ORR and PFS as per RECIST v1.1, assessed by investigator(5 years)
- Phase Ib/II: number of patients with dose interruptions and reduction(5 years)
- Phase II: BOR, ORR and PFS as per RECIST v1.1, assessed by investigator(5 years)
- Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: Tmax(5 years)
- Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: AUClast(5 years)
- Phase Ib/II: Changes from baseline of Pharmacodynamics (PD) markers in tumor tissue (p21, MDM2)(5 years)
- Phase Ib/II: anti-tumor activity endpoint (BOR, PFS)(5 years)
- Phase Ib/II: dose intensity(5 years)
- Phase Ib/II: Changes from baseline of Pharmacodynamics (PD) markers in blood (GDF-15)(5 years)
- Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: Cmax(5 years)
研究者
研究点 (1)
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