A Phase II Study of Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel as a First-line Treatment for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival time
研究概览
简要总结
The purpose of this study is to determine the efficacy of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma.
详细描述
This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel.
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
- •1.≥ 18 years old at the time of informed consent 2.Ability to provide written informed consent and HIPAA authorization 3.Untreated locally advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) as defined by National Comprehensive Cancer Network (NCCN) guidelines or, untreated metastatic PDAC (prior adjuvant therapy is permitted if it's been greater than 6 months since completion) 4.Histologically or cytologically confirmed PDAC 5.Confirmed PDAC that is measurable or evaluable per RECIST 1.1 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 7.Gastrointestinal symptoms (nausea, vomiting, and diarrhea) of Grade 1 or less 8.Adequate organ function as defined by:
- •Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN)
- •Total bilirubin level ≤ 2 x ULN
- •Creatinine level < 1.7mg/dL For patients with a Body Mass Index (BMI) > 30 kg/m2, lean body weight should be used to calculate the glomerular filtration rate (GFR).
- •Hemoglobin (Hgb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelets ≥ 80 x 10^9/L, Acceptable coagulation studies as demonstrated by prothrombin time (PT) within normal limits (+/-15%) unless they are on anticoagulation therapy
- •Life expectancy estimated at ≥ 3 months
排除标准
- •With any cancer other than PDAC in recent 5 years;
- •With myocardial infarction;
- •Uncontrolled hypertension (systolic pressure>150mmHg or diastolic pressure>100mmHg after treatment)
- •History of hemorrhage or thromboembolism in the last 6 months
- •Psychiatric history
- •Pregnant or breastfeeding
- •Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- •Autoimmune disease
- •Uncontrolled active infection
- •Other drugs that must be used during the trial may affect the metabolism of the experimental drugs (Sitagliptin, gemcitabine, nab-paclitaxel)
研究组 & 干预措施
Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel
Drug: Sitagliptin Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment.
Drug: Gemcitabine Gemcitabine will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 1000 mg/m2 depending on cohort assignment.
Drug: Nab-Paclitaxel Nab-Paclitaxel will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 125 mg/m2 depending on cohort assignment.
干预措施: Combination of sitagliptin+ gemcitabine + nab-paclitaxel (Drug)
结局指标
主要结局
Progression-free survival time
时间窗: from start of treatment until progression or last known follow up (i.e up to 2 years)
Rrogression-free survival time of PDAC patients
次要结局
- Disease control rate (DCR)(2 years)
- Objective Response Rate(from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1)
- Median Overall Survival (mOS) of the treated population(from start of treatment until death or last known follow up (i.e up to 2 years))
- Frequency of adverse events in the safety evaluable population(Time Frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years))