Phase I/II Randomized Trial of LB-100 Plus Doxorubicin Vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- Maximun Tolerated Dose (MTD) (Phase I)
研究概览
简要总结
A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles). After that, in the Phase II part, patients will be randomized (ratio 1:1) to either the experimental arm (LB-100 plus doxorubicin combination) or the control arm (doxorubicin alone) to, comparatively, evaluate the efficacy of the LB-100 plus doxorubicin combination vs. doxorubicin alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LB-100 plus doxorubicin
- LB-100 will be administered during the first 3 days of each cycle (days 1, 2, and 3) at RP2D as a 2-hour intravenous infusion (with 500 mL of physiological saline solution), every 3 weeks (21-day cycles until progression or intolerance).
- Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion after completion of LB-100, every 3 weeks (up to a maximum of 6 x 21-day cycles).
干预措施: LB-100 plus Doxorrubicin (Drug)
Doxorubicin alone
Control: Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion every 3 weeks (up to a maximum of 6 x 21-day cycles).
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Maximun Tolerated Dose (MTD) (Phase I)
时间窗: After six months
The MTD of LB-100 in combination with doxorubicin will be determined by assessing adverse events according to CTCAE v5.0.
Progression-free survival (PFS) (Phase II)
时间窗: After two years
Efficacy measured by median PFS according to RECIST v1.1
次要结局
- Adverse Events (Phase I and II)(Between six months and two years)
- Overall Response Rate (ORR) (Phase I and II)(Between six months and two years)
- EORTC QLQ-C30 questionnaire (Phase I and II)(Between six months and two years)
- Progression-free survival (PFS) (Phase I)(After six months)
- Overall survival (OS) (Phase I and II)(Between six months and two years)