Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Klute, Kelsey
Eligibility: https://clinicaltrials.gov/study/NCT04752696?term=NCT04752696&rank=1
Summary
Primary:
To assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first line gemcitabine-based therapy
Secondary:
To determine the overall survival (OS) of patients with metastatic PDAC treated with onvansertib in combination with nal-IRI, leucovorin, and 5-FU
To determine the duration of response (DOR) of patients with metastatic PDAC treated with onvansertib in combination with nal-IRI, leucovorin, and 5-FU
To assess the frequency and severity of adverse events (AEs) in patients with metastatic PDAC treated with onvansertib in combination with nal-IRI, leucovorin, and 5-FU
Exploratory:
To identify biomarkers related to sensitivity and resistance to treatment using patient-derived organoids, blood samples, and archival tissue biopsies.
To assess KRAS allelic burden through serial collection of circulating tumor DNA (ctDNA) and to identify blood-based biomarkers related to: (a) de novo sensitivity and (b) tumor evolution and resistance