NCT00412997已完成1 期
A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To determine the maximum-tolerated dose of LBH589
研究概览
简要总结
The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma
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
- •Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy.
- •World Health Organization (WHO) Performance Status of ≤ 2
- •Patients must have the adequate laboratory values
排除标准
- •Patients with a history of primary CNS tumors
- •Patients with any history of brain metastases
- •Patients with any peripheral neuropathy ≥ CTCAE grade 2
- •Patients with unresolved diarrhea ≥ CTCAE grade 2
- •Impairment of cardiac function
- •Impairment of gastrointestinal (GI) function or GI disease
- •Liver or renal disease
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LBH589
Experimental
干预措施: LBH589 (Drug)
结局指标
主要结局
To determine the maximum-tolerated dose of LBH589
时间窗: 1st cycle
次要结局
- Safety and tolerability assessed by AEs, SAEs and laboratory values.(Every 2 weeks)
- To characterize the pharmacokinetic (PK) profile of LBH589(every 3 cycles)
- To assess antitumor activity of LBH589(every 2 cycles)
研究者
研究点 (1)
Loading locations...
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