A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Estimate the MTD and/or RDE
研究概览
简要总结
The primary purpose of this dose escalation study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when administered orally once daily to adult patients with Multiple Myeloma (MM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Confirmed diagnosis of multiple myeloma that is relapsed and/or refractory for which no curative option exists.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •During the dose expansion part of the study patients must have measurable disease defined by at least 1 of the following 2 measurements:
- •Serum M-protein ≥ 0.5 g/dL
- •Urine M-protein ≥ 200 mg/24 hours
- •Serum free light chain (FLC) > 100 mg/L of involved FLC
排除标准
- •Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with LGH447:
- •Strong inhibitors or inducers of CYP3A4
- •CYP3A4 substrates with narrow therapeutic index
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
LGH447
Eligible patients will be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.
干预措施: LGH447 (Drug)
LGH447 and midazolam
Eligible patients will receive midazolam on two separate days, the first dose will be administered prior to the start of LGH447 and the second will be co-administered with LGH447. After that, the patients will continue to be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.
干预措施: LGH447 (Drug)
LGH447 and midazolam
Eligible patients will receive midazolam on two separate days, the first dose will be administered prior to the start of LGH447 and the second will be co-administered with LGH447. After that, the patients will continue to be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.
干预措施: midazolam (Drug)
结局指标
主要结局
Estimate the MTD and/or RDE
时间窗: 12 months
Incidence rate of dose limiting toxicity
次要结局
- Number of participants with adverse events and serious adverse events.(18 months)
- Anti-Myeloma activity associated with LGH447(18 months)
- Pharmacokinetic (PK) effects of LGH447(18 months)
- Pharmacodynamic (PD) effects of LGH447(18 months)
- Effect of multiple-doses of LGH447 on the PK of midazolam(6 months)