NCT00413322已完成1 期
A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
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
- 35
- 试验地点
- 3
- 主要终点
- to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors
研究概览
简要总结
This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed solid tumors
- •Advanced colorectal cancer or other adenocarcinomas
- •Tumor progression after standard chemotherapy, or where none yet approved
- •At least one unidimensionally measurable lesion
- •Karnofsky performance >= 70%
- •Life expectancy of at least 3 months
- •Age >= 18 years
- •Signed, written Institutional Review Board (IRB)-approved informed consent
- •Acceptable liver function:
- •Bilirubin <= 1.5 x upper limit of normal (ULN)
- •AST (SGOT) and ALT (SGPT) <= 2.5 x ULN, OR
- •AST (SGOT) and ALT (SGPT) <= 5 x ULN if liver metastasis
- •Acceptable renal function:
- •Serum creatinine within normal limits, OR
- •Calculated creatinine clearance of >= 60 mL/min/1.73 m2 for certain patients
- •Acceptable hematologic status:
- •Absolute neutrophil count (ANC) >= 1500 cells/mm3
- •Platelet count >= 100,000 (plt/mm3)
- •Hemoglobin >= 9 g/dL
- •Urinalysis: No clinically significant abnormalities
- •Acceptable coagulation status:
- •Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
- •For patients on anticoagulation therapy, status within therapeutic range
- •For men and women of child-producing potential, use of effective contraception
- •Tumors accessible for needle biopsy
排除标准
- •Significant cardiovascular disease.
- •A marked baseline prolongation of QT/QTc interval
- •Long QT syndrome
- •Required use of medication on dosing days that may cause torsade de pointes.
- •Infections requiring intravenous (IV) systemic therapy
- •Pregnant or nursing women
- •Treatment with chemotherapy or investigational therapy < 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin).
- •Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry.
- •Unwillingness or inability to comply with protocol procedures.
- •Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C
- •Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •Concurrent use of other investigational agent(s)
- •Serious concurrent medical illness
研究组 & 干预措施
Single-arm dose escalation
Experimental
干预措施: belinostat (Drug)
Single-arm dose escalation
Experimental
干预措施: 5-Fluorouracil (5-FU) (Drug)
结局指标
主要结局
to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors
时间窗: throughout the study
to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU
时间窗: throughout the study
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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