NCT04752696

Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 2 Study of Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Patients With Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Cardiff Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Onvansertib	Oral capsule
DRUG	Nanoliposomal irinotecan	Intravenous infusion
DRUG	Leucovorin	Intravenous infusion
DRUG	Fluorouracil	Intravenous infusion

Timeline

• Start date: 2021-05-25
• Primary completion: 2024-12-24
• Completion: 2024-12-24
• First posted: 2021-02-12
• Last updated: 2025-12-22

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study