NCT02937272进行中（未招募）1 期
A Phase 1 Study of LY3200882 in Patients With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 223
- 试验地点
- 18
- 主要终点
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •The participant must have histological or cytological evidence of cancer.
- •Have adequate organ function.
- •Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or
- •Are able to swallow capsules and tablets.
排除标准
- •Have moderate or severe cardiovascular disease.
- •Have a serious concomitant systemic disorder.
- •Have acute leukemia.
研究组 & 干预措施
LY3200882 Schedule 1 Escalation
Experimental
干预措施: LY3200882 (Drug)
LY3200882 Schedule 2 Escalation
Experimental
干预措施: LY3200882 (Drug)
LY3200882 Schedule 1 Expansion
Experimental
干预措施: LY3200882 (Drug)
LY3200882 Schedule 2 Expansion
Experimental
干预措施: LY3200882 (Drug)
LY3200882 + LY3300054
Experimental
干预措施: LY3200882 (Drug)
LY3200882 + LY3300054
Experimental
干预措施: LY3300054 (Drug)
LY3200882 + Gemcitabine + nab-Paclitaxel
Experimental
干预措施: LY3200882 (Drug)
LY3200882 + Gemcitabine + nab-Paclitaxel
Experimental
干预措施: Gemcitabine (Drug)
LY3200882 + Gemcitabine + nab-Paclitaxel
Experimental
干预措施: nab-Paclitaxel (Drug)
LY3200882 + Cisplatin + Radiation
Experimental
干预措施: LY3200882 (Drug)
LY3200882 + Cisplatin + Radiation
Experimental
干预措施: Cisplatin (Drug)
LY3200882 + Cisplatin + Radiation
Experimental
干预措施: Intensity Modulated Radiotherapy (Radiation)
Japanese Arm LY3200882
Experimental
干预措施: LY3200882 (Drug)
结局指标
主要结局
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
时间窗: Cycle 1 (28 days)
Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
时间窗: Baseline through Disease Progression or Death (estimated at up to 12 months)
次要结局
- Duration of Response (DoR)(Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months))
- PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882(Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles))
- ORR: Percentage of Participants with CR or PR(Baseline through Disease Progression or Death (estimated at up to 12 months))
- Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882(Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles))
- Overall Survival (OS)(Baseline to Date of Death from Any Cause (estimated at up to 12 months))
- Progression-Free Survival (PFS)(Baseline to Disease Progression or Death (estimated at up to 12 months))
研究者
研究点 (18)
Loading locations...
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