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

NCT07549958 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00000701UCI 24-105
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Patients with Adverse Events

  2 years

• Number of Patients who Discontinued Treatment Due to Reported Adverse Events

  2 years

• Objective Response Rate (ORR) by RECIST v1.1

  2 years

• Progression-Free Survival

  2 years

Study Arms (3)

Pitavastatin, 1mg, Dose Level -1

EXPERIMENTAL

Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.

Drug: Pitavastatin

Pitavastatin, 2 mg, Dose Level 0

EXPERIMENTAL

Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.

Drug: Pitavastatin

Pitavastatin, 4 mg, Dose Level +1

EXPERIMENTAL

Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.

Drug: Pitavastatin

Interventions

Pitavastatin DRUG

Given PO

Pitavastatin, 1mg, Dose Level -1; Pitavastatin, 2 mg, Dose Level 0; Pitavastatin, 4 mg, Dose Level +1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jennifer Valerin, MD, PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Assistant Clinical Profressor

Model Details: Dose Escalation

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)