NCT00667082已完成1 期
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or 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
- Celgene
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat
研究概览
简要总结
This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC inhibitors block modification of proteins regulating gene expression in cells. Both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Karnofsky Performance Status (KPS) at 70% or more.
- •Non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. Patients must have lesions that are evaluable by RECIST criteria.
- •All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to CTCAE (v. 3.0) Grade 1 or less(except for hemoglobin).
- •Adequate bone marrow, renal, liver function.
- •Signed informed consent.
排除标准
- •Recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy.
- •Intrathecal therapy.
- •Known brain metastases.
- •Significant cardiac disease.
- •Prior treatment with vorinostat or NPI-0052, or other HDACi (including valproic acid) or proteasome inhibitors.
- •Known allergy to any component of vorinostat. Prior hypersensitivity reaction of CTCAE Grade > 3 to therapy containing propylene glycol or ethanol.
- •Pregnant or breast-feeding women.
- •Concurrent, active secondary malignancy for which the patient is receiving therapy.
- •Significant active infection.
研究组 & 干预措施
NPI-0052 + Vorinostat Dose-Escalation
Experimental
4 dose-escalation cohorts
干预措施: NPI-0052 (marizomib) + vorinostat (Drug)
结局指标
主要结局
To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat
时间窗: continuously
次要结局
- To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat(continuous)
- To evaluate the anti-tumor activity of NPI-0052 and vorinostat(continuous)
- To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat(continuous)
研究者
研究点 (3)
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