NCT02570412No Longer Available不适用
Compassionate Use of Aldoxorubicin in Sarcoma Patients Who Have Failed Prior Chemotherapy
CytRx1 个研究点 分布在 1 个国家开始时间: 2015年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.
详细描述
This is a compassionate use protocol allowing sarcoma patients that have relapsed after prior therapies and are not eligible for other protocols involving the evaluation of aldoxorubicin to receive aldoxorubicin.
研究设计
- 研究类型
- Expanded Access
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
- •Metastatic or unrectable sarcoma that has either relapsed or was refractory to at leat 1 prior chemotherapy or immunotherapy regimen and for which no standard approved therapy exists
- •Must not be eligible for another CytRx-sponsored clinical trial
- •Able to provide complete medical records for review by the CytRx Medical Monitor
- •Able to receive treatment at a site that is participating or has participated in another CytRx-sponsored aldoxorubicin trial
- •Capable of providing informed consent and complying with trial procedures
- •ECOG performance status 0-2
- •Measurable or evaluable tumor lesions according to RECIST 1.1 criteria
- •Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study
- •Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating
排除标准
- •Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to screening for non-target lesion
- •Exposure to any investigational agent within 30 days of screening
- •Central nervous system metastases that are symptomatic
- •Laboratory values: Screening serum creatinine >1.5×ULN, ALT >3×ULN, or >5×ULN if liver metastases are present, total bilirubin >3×ULN, ANC <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <25% for females or <27% for males, coagulation tests (PT, PTT, INR) >1.5×ULN
- •Anion gap > 16 meq/L or arterial or venous blood pH < 7.
- •Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines
- •Current serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V
- •Baseline QTc >470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed
- •History or signs of active coronary artery disease with or without angina pectoris.
- •Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute LVEF <45% of predicted
- •History of HIV infection
- •Active, clinically signifiant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals
- •Major surgery within 3 weeks prior to enrollment
- •Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results
研究者
研究点 (1)
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