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

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 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 Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Pancreatic Cancer Metastatic
• Intervention / Treatment: Drug: Pitavastatin

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chao Family Comprehensive Cancer Center University of California, Irvine; Phone Number: 1-877-827-8839; Email: ucstudy@uci.edu
• Study Contact Backup: Name: University of California Irvine Medical

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Chao Family Comprehensive Cancer Center, University of California, Irvine
      • Contact: Jennifer Valerin, MD, PhD; Phone Number: 877-827-8839; Email: ucstudy@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pitavastatin, 1mg, Dose Level -1; Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.	Drug: Pitavastatin; Given PO
Experimental: Pitavastatin, 2 mg, Dose Level 0; Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.	Drug: Pitavastatin; Given PO
Experimental: Pitavastatin, 4 mg, Dose Level +1; Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.	Drug: Pitavastatin; Given PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended Phase II Dose	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients with Adverse Events	Number of Patients who received at least one dose of Gemcitabine and Nab-paclitaxel with Pitavastatin with any reported Adverse Events (AEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.	2 years
Number of Patients who Discontinued Treatment Due to Reported Adverse Events	Number of Patients who received at least one dose of Gemcitabine and Nab-paclitaxel with Pitavastatin requiring discontinuation of therapy due to reported AEs using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.	2 years
Objective Response Rate (ORR) by RECIST v1.1	Sum of Complete Response (CR) and Partial Response (PR) by RECIST v 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR for each dose cohort.	2 years
Progression-Free Survival	Determine the progression-free survival (PFS) for each cohort. PFS is measured from the date of randomization to the first date of disease progression.	2 years

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Jennifer Valerin, MD, PhD, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; pitavastatin
• Other Study ID Numbers: STUDY00000701; UCI 24-105 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes