NCT01976143已完成1 期
A Phase 1 Study to Evaluate the Effect of Nktr-102 for Injection (Etirinotecan Pegol) on the QT/QTC Interval in Patients With Advanced or Metastatic 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
- 33
- 试验地点
- 3
- 主要终点
- QTcF interval values
研究概览
简要总结
The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors
详细描述
This is an open-label study that will assess the effect of NKTR- 102 on cardiac ventricular repolarization, as characterized by QTcF (QT interval with Fridericia correction) interval values, in patients with advanced or metastatic solid tumors following administration of a single dose of NKTR-102.
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
- •Advanced or metastatic solid tumor refractory to standard therapy
- •Measurable or non-measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Resolution of acute toxic effects of prior chemotherapy and other cancer treatments
- •Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram
- •Adequate bone morrow and organ function
- •Electrolytes within normal limits
- •Stopped tobacco use for 4 weeks prior to day 1 and during the study
- •Agree to use adequate contraception
排除标准
- •Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1
- •Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study
- •Prior extensive anthracycline exposure
- •Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study
- •Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study
- •History of serious cardiovascular disease
- •Abnormal systolic blood pressure, diastolic blood pressure and/or heart rate
- •History of additional risk factors for Torsade de Pointes
- •Prolonged QTcF
- •Important abnormalities of the ECG that may interfere with the interpretation of QTc interval changes at screening
- •Implantable pacemaker or automatic implantable cardioverter defibrillator
- •UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37)
- •Any major surgery within 4 weeks prior to day 1
- •Concurrent treatment with other anticancer therapy
- •Untreated central nervous system metastases
- •Chronic or acute GI disorders resulting in diarrhea
- •Pregnancy or lactation
研究组 & 干预措施
NKTR-102
Experimental
A single 90 minute IV infusion of 220 mg/m2 NKTR-102
干预措施: NKTR-102 (Drug)
结局指标
主要结局
QTcF interval values
时间窗: Day -1 through Day 42
10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102
次要结局
- Pharmacokinetics (PK) and ECG Parameters(Day 1 through Day 42)
研究者
研究点 (3)
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