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

Phase 2

Not yet recruiting

• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: Combination of sitagliptin+ gemcitabine + nab-paclitaxel

• Registration Number: NCT05947825
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-09
• Study First Submitted QC: 2023-07-09
• Last Update Submitted: 2023-07-09
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17
• Study Start: 2023-07-30
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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:

1. Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN)
2. Total bilirubin level ≤ 2 x ULN
3. 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).
4. 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
5. Life expectancy estimated at ≥ 3 months

Exclusion Criteria

1. With any cancer other than PDAC in recent 5 years;
2. With myocardial infarction;
3. Uncontrolled hypertension (systolic pressure>150mmHg or diastolic pressure>100mmHg after treatment)
4. LVEF<50%
5. History of hemorrhage or thromboembolism in the last 6 months
6. Psychiatric history
7. Pregnant or breastfeeding
8. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
9. Autoimmune disease
10. Uncontrolled active infection
11. Other drugs that must be used during the trial may affect the metabolism of the experimental drugs (Sitagliptin, gemcitabine, nab-paclitaxel)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel	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 28-day cycle at a dose of 125 mg/m2 depending on cohort assignment.

Primary Outcome Measures

Name	Time	Method
Progression-free survival time	from start of treatment until progression or last known follow up (i.e up to 2 years)	Rrogression-free survival time of PDAC patients

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1	Objective Response Rate
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)	Median Overall Survival (mOS) of the treated population
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)	Frequency of adverse events in the safety evaluable population
Disease control rate (DCR)	8 weeks	Disease control rate (DCR)