A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Tmax of Venetoclax
研究概览
简要总结
A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL).
- •Participant must have histologically documented diagnosis of one of the following NHL subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), T-cell prolymphocytic lymphoma (T-PLL), Waldenström's macroglobulinemia (WM)
- •Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to two.
- •Must have adequate bone marrow, coagulation, renal and hepatic function as described in the protocol.
- •A female of non-childbearing potential as described in the protocol.
排除标准
- •History of currently active, clinically significant cardiovascular disease.
- •If the participant has had prior stem cell transplantation, it must have been more than 100 days prior to start of study drug, with no graft versus host disease, and no immunosuppression therapy.
- •evidence of transformation of the lymphoma immediately prior to study entry.
- •Evidence of central nervous system involvement by lymphoma.
研究组 & 干预措施
Ethinyl estradiol/Levonorgestrel and Venetoclax
Ethinyl estradiol/levonorgestrel is administered on Period 1 Day 1 and then again on Period 3 Day 1. Venetoclax is administered on Period 2 Day 1 and then daily thereafter.
干预措施: Venetoclax (Drug)
Ethinyl estradiol/Levonorgestrel and Venetoclax
Ethinyl estradiol/levonorgestrel is administered on Period 1 Day 1 and then again on Period 3 Day 1. Venetoclax is administered on Period 2 Day 1 and then daily thereafter.
干预措施: ethinyl estradiol/levonorgestrel (Drug)
结局指标
主要结局
Tmax of Venetoclax
时间窗: Up to approximately 59 days after initial study drug dose
Time to maximum plasma concentration (Tmax) of Venetoclax.
AUCt of Venetoclax
时间窗: Up to approximately 59 days after initial study drug dose
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax
t1/2 of Venetoclax
时间窗: Up to approximately 59 days after initial study drug dose
Terminal phase elimination half-life (t1/2) of Venetoclax.
t1/2 of EE/Levonorgestrel
时间窗: Up to approximately 59 days after initial study drug dose
Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel
Cmax of Venetoclax
时间窗: Up to approximately 59 days after initial study drug dose
Maximum plasma concentration (Cmax) of Venetoclax
Cmax of EE/Levonorgestrel
时间窗: Up to approximately 59 days after initial study drug dose
Maximum plasma concentration (Cmax) of EE/Levonorgestrel
AUCinf of EE/Levonorgestrel
时间窗: Up to approximately 59 days after initial study drug dose
AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.
Tmax of (ethinyl estradiol) EE/Levonorgestrel
时间窗: Up to approximately 59 days after initial study drug dose
Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel
AUCt of EE/Levonorgestrel
时间窗: Up to approximately 59 days after initial study drug dose
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel
次要结局
未报告次要终点