NCT07549958 PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)
| NCT ID | NCT07549958 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, Irvine |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2027-03-31 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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
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