NCT07549958
Recruiting
Phase 1
Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)
University of California, Irvine1 site in 1 country18 target enrollmentStarted: March 24, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Recommended Phase II Dose
Overview
Brief Summary
This is a phase 1, open-label clinical trial determining the recommended Phase 2 dose of Gemcitabine with Nab-paclitazel with or without Pitavastatin in subjects with unresectable pancreatic adenocarcinoma (uPDAC). These are subjects who are already receiving Gemcitabine for treatment of their disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old
- •Provision of a signed and dated ICF by the participant
- •Has a diagnosis of histologically or cytologically confirmed metastatic, recurrent, or locally advanced PDAC
- •Receiving a gemcitabine-based treatment regimen for a minimum of 2 and a maximum of 4 cycles without radiographic progression (ie SD or better).
- •Measurable disease per RECIST 1.1
- •Adequate organ (hematologic, hepatic, renal) function defined below:
- •Hemoglobin ≥ 9.0 g/dL (transfusion is allowed)
- •Platelets ≥ 100,000/mcL (transfusion is allowed)
- •ANC ≥ 1500/mcL
- •AST/ALT ≤ 3 x ULN (≤ 5 x ULN is allowable in cases of liver metastasis or Gilbert's Syndrome)
Exclusion Criteria
- •Uncontrolled significant clinical illness
- •Clinically significant autoimmune disease
- •Major surgery within 4 weeks of the first dose of registration
- •Known prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- •Concomitant use of statin therapy (to be discontinued 2 weeks prior to the start of C1D1).
- •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HbsAg) are eligible.
- •Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- •Patients with a known history of HIV.
- •Known active metastases in the central nervous system (unless stable by brain imaging studies for at least 1 month after last treatment)
- •Patients with QT interval corrected by Fridericia's formula (QTcF) \> 470 msec for both men and women on screening ECG are excluded.
Arms & Interventions
Pitavastatin
Experimental
Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.
Intervention: Pitavastatin (Drug)
Outcomes
Primary Outcomes
Recommended Phase II Dose
Time Frame: 2 years
Determine the recommended phase II dose (RP2D) of Pitavastatin in combination with Gemcitabine and nab-paclitaxel in treatment of uPDAC and determine any adverse events.
Secondary Outcomes
- Number of Patients with Adverse Events(2 years)
- Number of Patients who Discontinued Treatment Due to Reported Adverse Events(2 years)
- Objective Response Rate (ORR) by RECIST v1.1(2 years)
- Progression-Free Survival(2 years)
Investigators
Jennifer Brooke Valerin
HS Assistant Clinical Profressor
University of California, Irvine
Study Sites (1)
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