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

PDAC - Pancreatic Ductal Adenocarcinoma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05947825
• Other study ID #: Sitagliptin plus AG-Tianjin
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 30, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jihui Hao, Dr.
• Phone: 86-022-23340123
• Email: haojihui[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• PDAC - Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival time	Rrogression-free survival time of PDAC patients	from start of treatment until progression or last known follow up (i.e up to 2 years)
Secondary	Objective Response Rate	Objective Response Rate	from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1
Secondary	Frequency of adverse events in the safety evaluable 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)
Secondary	Median Overall Survival (mOS) of the treated population	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)
Secondary	Disease control rate (DCR)	Disease control rate (DCR)	8 weeks