Gemcitabine plus nab‑paclitaxel with or without pitavastatin for unresectable pancreatic adenocarcinoma

Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)

This phase 1 test looks at whether adding pitavastatin to ongoing gemcitabine‑based chemotherapy is safe and may help people with unresectable or metastatic pancreatic adenocarcinoma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Irvine (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Orange, California)
• Trial ID: NCT07549958 on ClinicalTrials.gov

What this trial studies

This open‑label Phase 1 trial adds pitavastatin to patients who are already receiving a gemcitabine‑based regimen (commonly gemcitabine with nab‑paclitaxel) to determine the recommended Phase 2 dose. Eligible participants have unresectable, recurrent, or metastatic pancreatic adenocarcinoma and must have completed 2–4 cycles of gemcitabine‑based therapy without radiographic progression. The study uses dose escalation and close safety monitoring with laboratory tests and imaging to identify tolerable dosing and track adverse events and tumor response per RECIST 1.1. The primary focus is on safety and dose selection, with secondary endpoints including preliminary anti‑tumor activity and feasibility of the combination.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically or cytologically confirmed unresectable, recurrent, or metastatic pancreatic adenocarcinoma who have received 2–4 cycles of a gemcitabine‑based regimen without progression, have ECOG performance status 0–2, adequate organ function, and no more than two prior lines of systemic therapy.

Not a fit: Patients with radiographic progression on gemcitabine, more than two prior systemic therapies, poor organ function, ECOG >2, or inability to attend the study site are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding pitavastatin could improve tumor control or tolerability when given alongside standard gemcitabine‑based chemotherapy for some patients.

How similar studies have performed: Preclinical data and small clinical reports suggest statins may have anti‑cancer activity, but using pitavastatin with chemotherapy in pancreatic cancer is experimental and has limited clinical evidence so far.

Eligibility criteria

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)
* Serum bilirubin ≤ 1.5 x ULN
* Serum albumin ≥ 3.0 g/dL
* Serum creatinine ≤ 1.5 x ULN OR creatinine clearance \> 60 mL/min
* ECOG PS 0-2
* 2 lines or less of prior treatment. Prior curative intent treatment (surgery and, if given in the adjuvant setting, systemic therapy and/or radiation) is permitted, regardless of time to recurrence, and does not constitute a line of therapy. This includes participants with residual disease after surgery, who received systemic therapy, chemoembolization, or radiotherapy.

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.
* A woman of childbearing potential who has a positive pregnancy test prior to initiating study treatment.
* Breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 5 months after the last dose of study treatment.
* Medicines known to inhibit or induce either CYP2C8, CYP2C9, or CYP3A4
* History of prior organ or stem cell transplant.
* Has an active infection requiring systemic therapy. Systemic treatment used prophylactically is allowable.
* Patients who are unable to swallow or retain oral medication.

Where this trial is running

Orange, California

• Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States (Recruiting)

Study contacts

• Principal investigator: Jennifer Valerin, MD, PhD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine

Conditions Pancreatic Cancer; Pancreatic Cancer Metastatic