NCT01613976已完成1 期
A Phase Ib, Open-label, Multi-center, Dose-escalation Study of Oral Panobinostat (LBH589) Administered With 5-Azacitidine (Vidaza®) in Adult Japanese Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML)
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
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Dose Limiting Toxicitiy(DLT)
研究概览
简要总结
The purpose of this study is to confirm the safety and tolerability of oral panobinostat (PAN) in combination with a fixed dose of 5-Azacitidine (5-Aza) in adult Japanese patients with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients who are candidates for treatment with 5-Aza and present with one of the following:
- •intermediate-2 or high-risk MDS according to the International Prognostic Scoring System (IPSS). OR
- •AML with multilineage dysplasia and maximum of 30% blasts (former RAEB-T according to FAB) OR CMML
- •Patient has an ECOG performance status of ≤ 2
- •Patients must have the following laboratory values unless elevations are considered due to MDS or leukemia: AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN; serum creatinine ≤ 1.5 x ULN; serum bilirubin (total and direct) ≤ 2 x ULN; electrolyte panel without clinically relevant abnormalities
排除标准
- •Patient who is planned for or has history of hematopoietic stem-cell transplantation (HSCT)
- •Patients with relapsed/refractory AML
- •Patient is receiving concurrent anti-cancer therapy
- •Patient has received prior treatment with deacetylase inhibitors (DACi)
- •Patient has received prior treatment with 5-Aza or 6-aza-2'-deoxycytidine (decitabine)
- •Patient has shown suspected hypersensitivity to 5-Aza or Mannitol
- •Patients with impaired cardiac function
- •Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pontes if such treatment cannot be discontinued or switched to a different medication prior to starting study treatment
- •Patients with clinical evidence of relevant mucosal or internal bleeding
- •Patient has any other concurrent severe and/or uncontrolled medical conditions
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Panobinostat and Azacitidine
Experimental
combination regimen
干预措施: Panobinostat (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicitiy(DLT)
时间窗: first 5 weeks of treatment period
DLT will be assessed during PK run-in period (up to 7 days) and 1st cycle (28 days)
次要结局
- PK parameter - Cmax(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
- PK parameter - Tmax(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
- PK parameter - AUC (AUC0-48, AUC0-tlast)(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
- PK parameter - T1/2 (apparent oral clearance, volume distribution)(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
- PK parameter - AUC0-inf(Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours)
- Trough level of PAN in combination with 5-Aza(Day 4, 5, 8 of the 1st cycle; pre-dose (0 hour))
- Frequency and severity of Adverse Events (AEs)(Participants will be followed for the duration of treatment, an expected average of 6 months)
- Laboratory abnormalities(duration of treatment, an expected average of 6 months)
研究者
研究点 (1)
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