A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Female subjects aged 19 years or older at the time of obtaining written informed consent.
- •2. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation.
- •Subjects who meet at least one of the following criteria:
- •Subjects who have been maintained on an olaparib dosing regimen of 300 mg (two 150 mg tablets) administered orally twice daily for at least 10 consecutive days.
- •Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice daily
- •Subjects with an estimated life expectancy of at least 12 weeks.
- •Subjects with a body mass index(BMI) between 18.50 and 30.00 kg/m² at screening.
排除标准
- •Subjects with a history of hypersensitivity to the investigational product or any of its components.
- •Subjects with any of the following concomitant conditions:
- •(1) Pneumonitis (2) Myelodysplastic syndrome or acute myeloid leukemia (3) Severe hepatic impairment(Child-Pugh class C). (4) Ongoing active infection or uncontrolled systemic disease (5) Active hepatitis B, hepatitis C, human immunodeficiency virus(HIV) infection, or syphilis.
- •3. Subjects who have received the following drug and non-drug treatments at screening:
- •Radiotherapy within 4 weeks prior to screening.
- •Other anticancer therapies within 4 weeks prior to screening.
- •Subjects who have undergone major surgery within 4 weeks prior to screening or who have not adequately recovered from a previous major surgery.
- •5. Subjects who have experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.
研究组 & 干预措施
Sequence A (Olaparib, RT)
Subjects are randomized into two sequence groups. In Sequence A, subjects receive R then T. T: DWZ2501(Olaparib) R: DW202510(Olaparib)
干预措施: DWZ2501 (Olaparib 150mg) (Drug)
Sequence B (Olaparib, TR)
Subjects are randomized into two sequence groups. In Sequence B, subjects receive T then R.
T: DWZ2501(Olaparib) R: DW202510(Olaparib)
干预措施: DWC202510 (Olaparib 150mg) (Drug)
Sequence A (Olaparib, RT)
Subjects are randomized into two sequence groups. In Sequence A, subjects receive R then T. T: DWZ2501(Olaparib) R: DW202510(Olaparib)
干预措施: DWC202510 (Olaparib 150mg) (Drug)
Sequence B (Olaparib, TR)
Subjects are randomized into two sequence groups. In Sequence B, subjects receive T then R.
T: DWZ2501(Olaparib) R: DW202510(Olaparib)
干预措施: DWZ2501 (Olaparib 150mg) (Drug)
结局指标
主要结局
Cmax
时间窗: Day 8, Day 16 after dose administration
Maximum plasma concentration of olaparib
AUCtau
时间窗: Day 8, Day 16 after dose administration
Area under the drug concentration-time curve of olapairb
次要结局
未报告次要终点