A Phase 1 Study to Evaluate the Potential Pharmacokinetic Interaction Between Entrectinib and Midazolam in Cancer Patients
概览
- 阶段
- 1 期
- 干预措施
- Entrectinib
- 疾病 / 适应症
- Advanced Solid Tumor
- 发起方
- Hoffmann-La Roche
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Cmax
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
This is an open-label study in advanced solid tumor patients to determine if entrectinib affects the pharmacokinetics of midazolam and any of its pharmacologically active metabolites.
研究者
入排标准
入选标准
- •Patients must meet the following criteria in order to be included in the research study:
- •Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors that are not responsive to standard therapies or for which there is no effective therapy.
- •At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy, respectively, at the time of the start of midazolam administration.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤
- •Adequate hematologic, liver and renal function.
- •Ability to understand the nature of this study and give written informed consent.
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Participation in another therapeutic clinical trial within 28 days prior to start of midazolam administration.
- •Prior treatment with entrectinib.
- •Known hypersensitivity or intolerance to midazolam or oral formulation excipients, including allergy to cherries.
- •Any condition (in the past 3 months) that may interfere with the conduct of study assessments or may interfere with the interpretation of study results.
- •History of non-pharmacologically induced prolonged QTc interval (e.g., repeated demonstration of a QTc interval \> 500 milliseconds from ECGs).
- •Known active infections that may interfere with the conduct of study assessments or may interfere with the interpretation of study results (bacterial, fungal, or viral, including human immunodeficiency virus positive).
- •Other Protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Entrectinib / Midazolam
干预措施: Entrectinib
Entrectinib / Midazolam
干预措施: Midazolam Hydrochloride
结局指标
主要结局
Cmax
时间窗: 4 weeks
Peak plasma concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
AUCinf
时间窗: 4 weeks
Area under the concentration-time curve from 0 to infinity of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
t1/2
时间窗: 4 weeks
Terminal half-life of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
AUClast
时间窗: 4 weeks
Area under the concentration-time curve from 0 to the last measurable concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
Tmax
时间窗: 4 weeks
Time of maximum concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.