Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients

Официальное название

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

Обзор

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.

Подробное описание

This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel.

Вмешательства

• Препарат Combination of sitagliptin+ gemcitabine + nab-paclitaxel
  Drug1: Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment. Drug2: 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. Drug3: 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.

Первичные конечные точки

• Progression-free survival time [Срок оценки: from start of treatment until progression or last known follow up (i.e up to 2 years)]

Вторичные конечные точки (4)

• Objective Response Rate [Срок оценки: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1]
• Frequency of adverse events in the safety evaluable population [Срок оценки: Time Frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years)]
• Median Overall Survival (mOS) of the treated population [Срок оценки: from start of treatment until death or last known follow up (i.e up to 2 years)]
• Disease control rate (DCR) [Срок оценки: 2 years]

Критерии участия

Критерии включения

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

Критерии исключения

• With any cancer other than PDAC in recent 5 years;
• With myocardial infarction;
• Uncontrolled hypertension (systolic pressure>150mmHg or diastolic pressure>100mmHg after treatment)
• LVEF<50%
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Institute & Hospital — Tianjing

Идентификаторы

NCT: NCT05947825 · SITGEM-CARE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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