NCT02739633Unknown2 期
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2016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
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) as assessed by RECIST.
研究概览
简要总结
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.
详细描述
The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
- •Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
- •Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
- •Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
- •Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization):
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- •Platelet count ≥ 100,000/mm3 (100 × 10^9/L)
- •Hemoglobin (Hgb) ≥ 9 g/dL.
- •Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
- •AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed.
- •Total bilirubin ≤ULN
- •Patient has a Karnofsky performance status (KPS) ≥
- •Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
- •Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
排除标准
- •History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- •Patients have uncontrolled bacterial, viral, or fungal infections
- •Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
- •Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
- •Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.
- •History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
研究组 & 干预措施
Genexol-PM + Gemcitabine
Experimental
Genexol-PM125 mg/m2 will be administered in combination with gemcitabine 1,000 mg/m2 weekly for 3 weeks followed by one week of rest. Each cycle is 28 days.
干预措施: Genexol-PM (Drug)
Genexol-PM + Gemcitabine
Experimental
Genexol-PM125 mg/m2 will be administered in combination with gemcitabine 1,000 mg/m2 weekly for 3 weeks followed by one week of rest. Each cycle is 28 days.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Objective response rate (ORR) as assessed by RECIST.
时间窗: 8 weeks
ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines. Response is confirmed at least 4 weeks later.
次要结局
- Progression free survival (PFS)(2 years)
- Overall survival (OS)(2 years)
- Disease control rate (DCR)(8 weeks)
- Number of participants with adverse events(Baseline up to Day 21 after the last dose of study treatment)
研究者
研究点 (1)
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