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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Given PO
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States
RECRUITINGRecommended 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.
Time frame: 2 years
Number of Patients with Adverse Events
Number of Patients who received at least one dose of Gemcitabine and Nab-paclitaxel with Pitavastatin with any reported Adverse Events (AEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.
Time frame: 2 years
Number of Patients who Discontinued Treatment Due to Reported Adverse Events
Number of Patients who received at least one dose of Gemcitabine and Nab-paclitaxel with Pitavastatin requiring discontinuation of therapy due to reported AEs using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.
Time frame: 2 years
Objective Response Rate (ORR) by RECIST v1.1
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR for each dose cohort.
Time frame: 2 years
Progression-Free Survival
Determine the progression-free survival (PFS) for each cohort. PFS is measured from the date of randomization to the first date of disease progression.
Time frame: 2 years
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
University of California Irvine Medical
CONTACT
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