NCT02117258已完成2 期
Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )
Zeria Pharmaceutical2 个研究点 分布在 2 个国家目标入组 167 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histological or cytological evidence of metastatic Pancreatic Adenocarcinoma, Measurable disease or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version criteria
- •Subjects with a life expectancy of at least 12 weeks,
- •Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2,
- •Subjects with the following adequate organ functions:
- •White blood cell count ≥3,000/μL (or absolute neutrophil count ≥1,500/μL) and ≤ 12,000/μL ,
- •Platelet count ≥100.0 × 10^9/L,
- •Hemoglobin ≥9.0 g/dL,
- •Serum creatinine ≤1.5 × the upper limit normal (ULN),
- •Total bilirubin ≤2.0 × ULN,
- •Serum aspartate transaminase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases), and
- •Serum alanine aminotransferase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases).
排除标准
- •Subjects received the following previous therapies for Pancreatic Adenocarcinoma:
- •Surgery within the 4 weeks prior to randomization,
- •Radiation and chemoradiation within the 12 weeks prior to randomization,
- •Radiation for pain relief within the 4 weeks prior to randomization,
- •Gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization,
- •Chemotherapy except GEM used as an adjuvant on surgery within the 4 weeks prior to randomization,
- •Gemcitabine ≥600 mg/m^2 as sensitizer for chemoradiation,
- •Gemcitabine <600 mg/m^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization,
- •Gemcitabine used for systemic chemotherapy, or
- •Systemic chemotherapies except GEM within the 4 weeks prior to randomization.
研究组 & 干预措施
Z-360 120mg+Gemcitabine
Experimental
Z-360 120 mg will be taken orally, twice daily (BID) after a meal.
干预措施: Z-360 (Drug)
Z-360 60mg+Gemcitabine
Experimental
Z-360 60 mg will be taken orally, twice daily (BID) after a meal.
干预措施: Z-360 (Drug)
Z-360 240mg+Gemcitabine
Experimental
Z-360 240 mg will be taken orally, twice daily (BID) after a meal.
干预措施: Z-360 (Drug)
Placebo+Gemcitabine
Placebo Comparator
Placebo will be taken orally, twice daily (BID) after a meal.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: Approximately 24 months
次要结局
- Progression Free Survival (PFS)(Approximately 24 months)
- Time to Treatment Failure(Approximately 24 months)
- Quality of Life(Approximately 24 months)
- Safety parameters(Approximately 24 months)
- Pharmacokinetics(Day1)
- Response Rate(Approximately 24 months)
- Benefit Rate(Approximately 24 months)
研究者
研究点 (2)
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