NCT02078609已完成1 期
A Phase I, Multicenter, Open-label Study of Oral LGH447 in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence rate of dose limiting toxicities (DLTs) of LGH447 monotherapy arm in patients with AML or MDS and of LGH447 + midostaurin in patients with AML
研究概览
简要总结
This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LGH447 monotherapy arm
Experimental
LGH447 monotherapy in patients with AML or MDS
干预措施: LGH447 (Drug)
LGH447 + midostaurin combination arm
Experimental
LGH447 + midostaurin in patients with AML
干预措施: LGH447 + midostaurin (Drug)
结局指标
主要结局
Incidence rate of dose limiting toxicities (DLTs) of LGH447 monotherapy arm in patients with AML or MDS and of LGH447 + midostaurin in patients with AML
时间窗: 28 days post study treatment
Frequency and characteristics of dose limiting toxicities
次要结局
- Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of the LGH447 monotherapy arm in patients with AML or MDS and of the LGH447 + midostaurin treatment arm in patients with AML(weekly to bi-weekly up to 1.5 years)
- PK parameters of the LGH447 monotherapy arm in patients with AML or MDS and of the LGH447 + midostaurin treatment arm in patients with AML(days 1, 2, 15, 16, 29, 30, 44, 57, and approximately monthly through Cycle 3)
- Changes between pre- and post-treatment levels of pS6RP and p4EBP1 in bone marrow aspirates and p4EBP1 in peripheral blood of the LGH447 monotherapy arm in patients with AML or MDS and of the LGH447 + midostaurin treatment arm in patients with AML(screening, days 1 and 29 up to 1.5 years)
- Anti-tumor activity in AML or high risk MDS associated wtih LGH447(Day 29 up to 1.5 years)
- Anti-tumor activity in AML or high risk MDS associated wtih LGH447 in combination with midostaurin(Day 29 up to 1.5 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic MalignanciesMultiple MyelomaNCT02160951Novartis Pharmaceuticals13
已完成
1 期
A Study of IMP4297 in Patients With Advanced Solid TumorsAdvanced Solid TumoursBreast CancerOvarian CancerProstate CancerNCT03508011Impact Therapeutics, Inc.57
已完成
1 期
Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy VolunteersHerpes Simplex VirusNCT06435507Innovative Molecules GmbH18
已完成
1 期
A Study of LGK974 in Patients With Malignancies Dependent on Wnt LigandsBRAF Mutant Colorectal CancerTriple Negative Breast CancerHead and Neck Squamous Cell CancerCervical Squamous Cell CancerEsophageal Squamous Cell CancerLung Squamous Cell CancerPancreatic CancerMelanomaNCT01351103Novartis Pharmaceuticals185
进行中（未招募）
1 期
A Phase 1 Study of BB3008 in Participants With Advanced Solid TumorsAdvanced Solid TumorNCT06143007Broadenbio Ltd., Co.42