Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)
University of California, Irvine
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPitavastatin
Given PO
Location
- Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, California