Can a statin boost chemo for pancreatic cancer?
NCT ID NCT07549958
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests adding the cholesterol-lowering drug pitavastatin to standard chemotherapy (gemcitabine and nab-paclitaxel) as maintenance therapy for people with advanced pancreatic cancer that cannot be removed by surgery. About 18 adults whose disease is stable after initial chemo will receive the combination to find the safest dose and check for side effects. The goal is to see if this approach can help keep the cancer under control longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Chao Family Comprehensive Cancer Center, University of California, Irvine
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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