A Phase I, Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics of Orally Administered [14C]-Roniciclib (BAY 1000394) in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- AUC(0-tlast) of roniciclib in plasma
研究概览
简要总结
The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Male or female subjects aged ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- •Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory 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 bone marrow, liver, and renal functions as assessed by laboratory requirements to be conducted within 14 days prior to the first dose of study drug:
排除标准
- •Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism
- •History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class III or IV, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. Accepted exemptions are bisphosphonates, luteinising hormone releasing hormone (LHRH) agonists for prostate cancer, and mitotane for adrenal carcinoma.
- •Radiotherapy within 3 weeks prior to the first dose of study drug. Palliative radiotherapy will be allowed
- •Intake of strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin , rifampin and St. John's Wort)
研究组 & 干预措施
Arm 1
Open label non-randomized non-controlled mass balance study in Cycle 1
干预措施: roniciclib (BAY 1000394) (Drug)
Arm 2
Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles
干预措施: roniciclib (BAY 1000394) (Drug)
结局指标
主要结局
AUC(0-tlast) of roniciclib in plasma
时间窗: up to 336 hours
Cmaxof roniciclib in plasma
时间窗: up to 336 hours
Amount of Roniciclib in urine as percentage of the dose of total radioactivity.
时间窗: Up to 336 hours
Amount of Roniciclib in feces as percentage of the dose of total radioactivity.
时间窗: Up to 336 hours
Amount of Roniciclib in vomit as percentage of the dose of total radioactivity
时间窗: Up to 336 hours
Cmax of total radioactivity in whole blood and plasma
时间窗: up to 336 hours
AUC of roniciclib in plasma
时间窗: up to 336 hours
AUC(0-tlast) of total radioactivity in whole blood and plasma
时间窗: Up to 336 hours
AUC of total radioactivity in whole blood and plasma
时间窗: up to 336 hours
次要结局
未报告次要终点