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

Detailed 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…

Interventions

Drug
Pitavastatin
Given PO

Location

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California
ucstudy@uci.edu 877-827-8839

Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)

Summary

Eligibility

Interventions

Location

Compensation

Run this study?

Details

Conditions