ACTRN12614001328662终止2 期
A Multi-center, Phase II, Open-label Study of Efficacy and Safety of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adult patients 18 years of age or older and providing informed consent
- •2. ECOG performance status of less than or equal to 2.
- •3. Relapsed or refractory to previous treatment of PTCL/CTCL
- •4. Acceptable organ function
- •5. Non pregnant or not breastfeeding
排除标准
- •1. Known active central nervous system (CNS) lymphoma.
- •2. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (except glucocorticoids) less than 4 weeks prior to Cycle 1 Day 1, and radio-immunotherapy 6 weeks prior to Cycle 1 Day 1.
- •3. Have not adequately recovered from the side effects of previous antineoplastic agents prior to dosing.
- •4. Active graft-versus-host disease after allogeneic stem cell transplantation.
- •5. Autologous stem cell transplantation less than 100 days prior to Cycle 1 Day 1
- •6. Concurrent therapy with approved or investigational anti-cancer drugs
- •7. Major surgery within last 2 weeks
- •8. Any other significant concomitant illness
- •9. Unstable cardiovascular function
- •10. Uncontrolled infection
- •11. Active HIV or hepatitis infection
- •12. Serious psychiatric or medical condition
- •13. Unable to swallow capsules
研究者
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