Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- Disease control rate (DCR) [8 weeks]
Disease control rate (DCR)
Eligibility Criteria
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:
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Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN)
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Total bilirubin level ≤ 2 x ULN
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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).
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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
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Life expectancy estimated at ≥ 3 months
Exclusion Criteria:
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With any cancer other than PDAC in recent 5 years;
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With myocardial infarction;
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Uncontrolled hypertension (systolic pressure>150mmHg or diastolic pressure>100mmHg after treatment)
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LVEF<50%
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History of hemorrhage or thromboembolism in the last 6 months
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Psychiatric history
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Pregnant or breastfeeding
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Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
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Autoimmune disease
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Uncontrolled active infection
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Other drugs that must be used during the trial may affect the metabolism of the experimental drugs (Sitagliptin, gemcitabine, nab-paclitaxel)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tianjin Medical University Cancer Institute and Hospital
Investigators
- Principal Investigator: Jihui Hao, Dr., Tianjin Medical University affiliated Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Sitagliptin plus AG-Tianjin