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

Primary Purpose

PDAC - Pancreatic Ductal Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Combination of sitagliptin+ gemcitabine + nab-paclitaxel
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PDAC - Pancreatic Ductal Adenocarcinoma focused on measuring PDAC, sitagliptin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 0-2 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 109/L, Platelets ≥ 80 x 109/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 Exclusion Criteria: 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel

    Arm Description

    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 28-day cycle at a dose of 125 mg/m2 depending on cohort assignment.

    Outcomes

    Primary Outcome Measures

    Progression-free survival time
    Rrogression-free survival time of PDAC patients

    Secondary Outcome Measures

    Objective Response Rate
    Objective Response Rate
    Frequency of adverse events in the safety evaluable population
    Frequency of adverse events in the safety evaluable population
    Median Overall Survival (mOS) of the treated population
    Median Overall Survival (mOS) of the treated population
    Disease control rate (DCR)
    Disease control rate (DCR)

    Full Information

    First Posted
    July 9, 2023
    Last Updated
    July 9, 2023
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05947825
    Brief Title
    Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
    Official Title
    The Safety and Tolerance of Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in Subjects With Locally Advanced and Metastatic Pancreatic Adenocarcinoma: an Open, One-Armed, Single-Center, Phase Ⅱ Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the safety and tolerance of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma.
    Detailed Description
    This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel. This study will enroll 30 PDAC patients over 12-15 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PDAC - Pancreatic Ductal Adenocarcinoma
    Keywords
    PDAC, sitagliptin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel
    Arm Type
    Experimental
    Arm Description
    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 28-day cycle at a dose of 125 mg/m2 depending on cohort assignment.
    Intervention Type
    Drug
    Intervention Name(s)
    Combination of sitagliptin+ gemcitabine + nab-paclitaxel
    Intervention Description
    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 28-day cycle at a dose of 125 mg/m2 depending on cohort assignment.
    Primary Outcome Measure Information:
    Title
    Progression-free survival time
    Description
    Rrogression-free survival time of PDAC patients
    Time Frame
    from start of treatment until progression or last known follow up (i.e up to 2 years)
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate
    Description
    Objective Response Rate
    Time Frame
    from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1
    Title
    Frequency of adverse events in the safety evaluable population
    Description
    Frequency of adverse events in the safety evaluable population
    Time Frame
    Time Frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years)
    Title
    Median Overall Survival (mOS) of the treated population
    Description
    Median Overall Survival (mOS) of the treated population
    Time Frame
    from start of treatment until death or last known follow up (i.e up to 2 years)
    Title
    Disease control rate (DCR)
    Description
    Disease control rate (DCR)
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 0-2 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 109/L, Platelets ≥ 80 x 109/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 Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jihui Hao, Dr.
    Phone
    86-022-23340123
    Email
    haojihui@tjmuch.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jihui Hao, Dr.
    Organizational Affiliation
    Tianjin Medical University affiliated Cancer Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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