Back to search results

Phase 1 Study of Gemcitabine with or without Pitavastatin for Pancreatic Cancer

This study is testing a drug called Pitavastatin (given by mouth) in combination with Gemcitabine and Nab-paclitaxel for people with pancreatic cancer that cannot be removed by surgery (unresectable pancreatic adenocarcinoma). You may be able to join if you are at least 18 years old, have been diagnosed with metastatic, recurrent, or locally advanced pancreatic cancer, and are already receiving Gemcitabine-based treatment without your cancer getting worse. The main goal of this study is to find the best dose of these medicines to recommend for future studies. The study plans to enroll 18 participants, but its current status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It aims to enroll 18 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Recommended Phase II Dose, is measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07549958

PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, Irvine
~18 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Pitavastatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase II Dose
Measured over 2 years

Conditions

Pancreatic Cancer
Pancreatic Cancer Metastatic

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jennifer Valerin, MD, PhD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Recommended Phase II Dose2 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.