An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 73
- 试验地点
- 6
- 主要终点
- Brentuximab vedotin blood concentrations +/- rifampin
研究概览
简要总结
The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adequate organ function (Special Populations: serum bilirubin >2 mg/dL or creatinine clearance <50 mL/min)
- •ECOG performance status <2 (Special Populations: <4)
- •Relapsed or refractory CD30-positive malignancy
排除标准
- •Receiving prohibited medication within 4 weeks
- •Poor liver function (Child-Pugh class C)
- •Current diagnosis of primary cutaneous ALCL
- •Acute or chronic graft-versus-host disease
研究组 & 干预措施
1
midazolam +/- brentuximab vedotin
干预措施: midazolam (Drug)
1
midazolam +/- brentuximab vedotin
干预措施: brentuximab vedotin (Drug)
2
brentuximab vedotin +/- rifampin
干预措施: brentuximab vedotin (Drug)
2
brentuximab vedotin +/- rifampin
干预措施: rifampin (Drug)
3
brentuximab vedotin +/- ketoconazole
干预措施: ketoconazole (Drug)
3
brentuximab vedotin +/- ketoconazole
干预措施: brentuximab vedotin (Drug)
4
special populations
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Brentuximab vedotin blood concentrations +/- rifampin
时间窗: 6 weeks
Brentuximab vedotin in urine, feces, and blood
时间窗: 1 week
Midazolam blood concentrations +/- brentuximab vedotin
时间窗: 3 weeks
Brentuximab vedotin blood concentrations in special populations
时间窗: 3 weeks
Brentuximab vedotin blood concentrations +/- ketoconazole
时间窗: 6 weeks
次要结局
- Incidence of adverse events and laboratory abnormalities(6 weeks)