An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of Roniciclib in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 14
- 主要终点
- Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole)
研究概览
简要总结
To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients.
To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
- •Adequate liver, renal and bone-marrow functions as assessed by laboratory values.
- •ECOG Performance Status of 0 - 2 and life expectancy of at least 12 weeks.
- •Subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug.
排除标准
- •Medical and surgical history:
- •Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism.
- •History of cardiac disease: congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management)
- •Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •Active clinically serious infections of Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03) > Grade
- •Symptomatic metastatic brain or meningeal tumors unless the subject is >3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
- •Seizure disorder requiring therapy (such as steroids or anti-epileptics).
- •History of organ allograft.
- •Use of strong inhibitors and/or inducers of CYP3A4 in the 14 days before study treatment
研究组 & 干预措施
Roniciclib + Itraconazole
Pharmacokinetics and safety in patients with advanced solid tumor
干预措施: Roniciclib (BAY 1000394) (Drug)
Roniciclib + Itraconazole
Pharmacokinetics and safety in patients with advanced solid tumor
干预措施: Itraconazole (Sporanox) (Drug)
结局指标
主要结局
Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole)
时间窗: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing
Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole)
时间窗: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing
Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole)
时间窗: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing
Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole)
时间窗: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing
次要结局
- Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole(up to 15 months)
- Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)(Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing)
- Area under the concentration vs. time curve from zero to 24 hr (AUC) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)(Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing)
- Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole(up to 15 months)
- East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole(up to 15 months)
- Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole(up to 15 months)
- Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole(up to 15 months)
- Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole(up to 15 months)