A Single-arm Multicentre Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Who Have Not Previously Received Therapy for Metastatic Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 28
- 主要终点
- Overall Response (OR)
研究概览
简要总结
This study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (S095013) in combination with oxaliplatin, 5-Fluorouracil (5-FU) and levoisomer form of leucovorin (LLV). S095013, oxaliplatin, 5-FU and LLV will be administered on days 1 and 15 of each 28-day cycle. Cycles will continue until clinical or radiological progressive disease, unacceptable study medication-related toxicity or withdrawal from study. During the treatment period participants will have study visits on day 1, 3, 15, and 17 of each cycle, some of which may occur as a home visit. At least 30 days after treatment has ended a end of treatment visit will occur and then participants will be followed for survival every month via telephone or email until death or end of the study. Study visits may include questionnaires, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or non-pregnant and non-lactating female ≥ 18 years of age.
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
- •Initial diagnosis of metastatic disease (as per American Joint Committee on Cancer 8th Edition [AJCC 2017]) must have occurred ≤ 6 weeks prior to screening.
- •Participant has one or more metastatic lesions measurable by CT-scan (or MRI), if the participant is allergic to CT contrast media, according to RECIST Version 1.1 criteria.
- •ECOG PS of 0 or 1 at screening and within 7 days prior to first dosing.
- •Participant has adequate hematological, biochemical, hepatic, and renal function parameters.
排除标准
- •Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy (palliative surgery, palliative radiotherapy and placement of biliary stent/tube are permitted).
- •Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related relevant toxicities are present.
- •Participant has only locally advanced disease.
- •Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or any components of 5-FU, LLV or oxaliplatin products.
研究组 & 干预措施
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
干预措施: LLV (levoisomer form of leucovorin) (Drug)
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
干预措施: 5- FU (5-Fluorouracil) (Drug)
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
干预措施: Oxaliplatin (Drug)
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
干预措施: Irinotecan liposome injection (S095013) (Drug)
结局指标
主要结局
Overall Response (OR)
时间窗: Through the end of study treatment (approximately 16 months after study start)
OR is defined as complete response (CR) or partial response (PR), as assessed by the independent central review (ICR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
次要结局
未报告次要终点