Actively Recruiting
Phase Ib Randomized Study of Gemcitabine With Nab-paclitaxel With or Without Pitavastatin in Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma
Led by University of California, Irvine · Updated on 2026-05-04
18
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 1, open-label clinical trial to find the recommended dose for phase 2 of Gemcitabine combined with Nab-paclitaxel, with or without Pitavastatin, in people with unresectable pancreatic adenocarcinoma. This trial focuses on individuals who are already receiving Gemcitabine treatment for their disease. The trial is led by the University of California, Irvine, and aims to understand the best dosing to move forward in treatment development. Participants receive Pitavastatin orally once daily on days 1-28 of each 4-week cycle, alongside their ongoing Gemcitabine and Nab-paclitaxel treatment. The study includes three dosing levels of Pitavastatin: 1 mg, 2 mg, and 4 mg. The trial is non-randomized and open-label, meaning all participants know which dose they receive. This dosing schedule helps researchers assess safety and optimal dosing for future studies. During the trial, participants will undergo various assessments including monitoring for adverse events, evaluating tumor response using RECIST 1.1 criteria, and tracking progression-free survival over two years. Researchers will also collect lab tests and physical exams to check organ function and overall health. The main goal is to determine the recommended dose for phase 2 while ensuring participant safety throughout the study period, which may last up to two years.
CONDITIONS
Brief Title
PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed and dated informed consent form
- Diagnosed with metastatic, recurrent, or locally advanced pancreatic adenocarcinoma confirmed by histology or cytology
- Receiving gemcitabine-based treatment for 2 to 4 cycles without radiographic progression (stable disease or better)
- Measurable disease according to RECIST 1.1 criteria
- Adequate organ function including hemoglobin ≥ 9.0 g/dL, platelets ≥ 100,000/mcL, ANC ≥ 1500/mcL, AST/ALT ≤ 3 times upper limit (≤ 5 times allowed for liver metastasis or Gilbert's Syndrome), bilirubin ≤ 1.5 times upper limit, albumin ≥ 3.0 g/dL, and creatinine clearance > 60 mL/min or serum creatinine ≤ 1.5 times upper limit
- Eastern Cooperative Oncology Group performance status 0 to 2
- No more than 2 prior lines of treatment, excluding curative intent treatments such as surgery or radiation
You will not qualify if you...
- Uncontrolled significant clinical illness
- Clinically significant autoimmune disease
- Major surgery within 4 weeks before first dose
- Prior malignancy active within last 3 years except certain cured cancers
- Current use of statin therapy (must stop 2 weeks before study start)
- Active hepatitis B with detectable viral load unless on suppressive therapy
- Untreated or active hepatitis C infection
- Known history of HIV
- Active central nervous system metastases unless stable for at least 1 month
- QTcF interval > 470 msec on ECG screening
- Positive pregnancy test in women of childbearing potential
- Breastfeeding or planning to conceive or father children during study and 5 months after
- Use of medicines that inhibit or induce CYP2C8, CYP2C9, or CYP3A4 enzymes
- History of organ or stem cell transplant
- Active infection requiring systemic therapy (except prophylactic treatment allowed)
- Unable to swallow or retain oral medication
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Pitavastatin orally once daily on days 1-28 of each 4-week cycle alongside gemcitabine-based treatment as maintenance therapy for unresectable pancreatic adenocarcinoma.
Visits occur every 4 weeks with dosing daily during each cycle
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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