UnknownPhase 2

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

30 participantsStarted 2023-07-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.≥ 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

What they're measuring

Progression-free survival time

Timeframe: from start of treatment until progression or last known follow up (i.e up to 2 years)

Trial details

NCT IDNCT05947825

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

Contact for this trial

Jihui Hao, Dr.

86-022-23340123 haojihui@tjmuch.com

View on ClinicalTrials.gov More PDAC - Pancreatic Ductal Adenocarcinoma trials