NCT01706835已完成1 期
An Open-Lable Phase 1 Study to Investigate the Pharmacolkinetics of Aldoxorubicin (INNO-206;DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects 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
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This is a phase 1 open-label study to investigate the pharmacokinetics of aldoxorubicin administered as a 30 minute infustion every 3 weeks for up to 8 cycles in subjects with advanced solid tumors.
详细描述
An Open-Label Phase 1 Study to Investigate the Pharmacokinetics of Aldoxorubicin Administered as a 30 Minute Infusion Every 3 Weeks in Subjects with Advanced Solid Tumors.
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
- •Age ≥18 years, male or female.
- •Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.
- •Subjects who have received prior radiation therapy with stable central nervous system (CNS) metastasis with no progression of brain metastasis by CT/MRI scan in last 4 weeks.
- •Capable of providing informed consent and complying with trial procedures.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-
- •Life expectancy >12 weeks.
- •Measurable or evaluable disease.
- •Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. [Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.].
- •Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- •Geographic accessibility to the site.
排除标准
- •Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment less than 4 weeks prior to the Screening Visit.
- •Exposure to any investigational agent within 30 days of the Screening Visit.
- •Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or 5 times the ULN in liver metastases, total bilirubin greater than 3 times the ULN, white blood cell (WBC) count <3500/mm3, absolute neutrophil (ANC) count < 2000/mm3, platelet concentration <100,000/mm3, hematocrit level <25% for females or <28% for males (transfusion is allowed during screening).
- •Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
- •Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- •Recent history (within 6 months) or current signs of active coronary artery disease with or without angina pectoris.
- •Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted.
- •Known history of HIV infection.
- •Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals.
- •Major surgery within 4 weeks prior to treatment.
- •Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- •Any condition that is unstable and could jeopardize the subject's participation in the study.
研究组 & 干预措施
Aldoxorubicin
Experimental
Aldoxorubicin dosages of 230 mg/m2 or 350 mg/m2 will be given as a 30 minute infusion every 3 weeks for 8 cycles.
干预措施: aldoxorubicin (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: up to 3 months
Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.
次要结局
- Safety(up to 6 months)
研究者
研究点 (1)
Loading locations...
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