NCT03326102已完成2 期
A Multi-national,Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®,Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 15
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
- •Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
- •Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
- •Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).
排除标准
- •Subjects who have received prior taxane therapy in the metastatic setting
- •Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
- •Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
- •Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
- •Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).
研究组 & 干预措施
DHP107
Experimental
The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1.
Total 48 subjects (including PK subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days.
干预措施: DHP107 (Drug)
IV paclitaxel
Experimental
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
干预措施: IV Paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: Every 8 weeks upto 18 months from randomization date
ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria
次要结局
- Progression free survival(PFS)(Up to 18 months from randomization date)
- Overall survival(OS)(Up to 36 months from FPI)
- Duration of response(DOR)(Up to 18 months from randomization date)
- Quality of life(QoL)(after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months)
- PK(The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of Cycle 1)
- Time to treatment failure(TTF)(Up to 18 months from randomization date)
- Disease control rate(DCR)(Up to 18 months from randomization date)
研究者
研究点 (15)
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