A Multi-centre, Open-Label, Randomized, Two-Stage, Two-treatment, Two-Period, Multiple-Dose, Crossover Bioequivalence Study to Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variable - Cmax
研究概览
简要总结
This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer.
详细描述
This study will be conducted in two stages. Stage 1 enrolls patients who have been taking BR2022-1 as existing therapy, and results will be evaluated before deciding whether to proceed with the Stage 2 part of the study and enroll more patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 19 -74 at the time of consent
- •Those who voluntarily signed the informed consent to participate in this study
- •Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking stable doses of olaparib for more than 3 months before screening.
排除标准
- •Those who have a history of severe hypersensitivity to drugs that include the ingredients of the investigational product or have a history of clinically significant hypersensitivity reactions
- •Those who have gastrointestinal disorders (e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or have had surgeries (excluding appendectomy or hernia surgery) that may affect the absorption of the investigational products
- •Those who are pregnant, suspected of pregnancy, or nursing
研究组 & 干预措施
Sequence 1 (TR)
Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 1, subjects receive T (1d-7d) then R (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None
干预措施: Olaparib 150 MG (Drug)
Sequence 2 (RT)
Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 2, subjects receive R (1d-7d) then T (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None
干预措施: Olaparib 150 MG (Drug)
结局指标
主要结局
Pharmacokinetic variable - Cmax
时间窗: From Day 6 to Day 7 after dose administration
Maximum plasma concentration of BR2022 and BR2022-1
Pharmacokinetic variable - AUCtau
时间窗: From Day 6 to Day 7 after dose administration
Area under the drug concentration-time curve over the time interval from Day 6 to Day 7 after dose administration
次要结局
未报告次要终点