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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Recommended Phase II Dose
Timeframe: 2 years
Trial details
NCT IDNCT07549958
SponsorUniversity of California, Irvine
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-03-31
Contact for this trial
Chao Family Comprehensive Cancer Center University of California, Irvine