To hear about similar clinical trials, please enter your email below
Trial Title:
Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
NCT ID:
NCT05947825
Condition:
PDAC - Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Sitagliptin Phosphate
Paclitaxel
Gemcitabine
Conditions: Keywords:
PDAC
sitagliptin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Combination of sitagliptin+ gemcitabine + nab-paclitaxel
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.
Arm group label:
Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel
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.
Criteria for 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:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 30, 2023
Completion date:
August 1, 2024
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05947825
