NCT03829410

Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation

A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS Mutation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Cardiff Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily on Day 1-5 and Day 15-19 of each 28-day cycle, in combination with FOLFIRI + Bevacizumab, as second-line treatment in adult participants who have metastatic colorectal cancer with a KRAS mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.

Conditions

• Metastatic Colorectal Cancer
• KRAS Gene Mutation

Interventions

Type	Name	Description
DRUG	Onvansertib	Onvansertib orally.
BIOLOGICAL	Bevacizumab	Bevacizumab intravenously.
DRUG	FOLFIRI	FOLFIRI intravenously.

Timeline

• Start date: 2019-06-24
• Primary completion: 2024-01-29
• Completion: 2024-01-29
• First posted: 2019-02-04
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study