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临床试验/NCT01613976
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)

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年8月最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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