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

NCT ID: NCT05947825

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2024-08-01

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.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: 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.

Group Type: EXPERIMENTAL

Combination of sitagliptin+ gemcitabine + nab-paclitaxel

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jihui Hao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University affiliated Cancer Hospital

Central Contacts

Jihui Hao, Dr.

Role: CONTACT

haojihui@tjmuch.com

86-022-23340123

Other Identifiers

Sitagliptin plus AG-Tianjin

Identifier Type: -

Identifier Source: org_study_id