CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Onvansertib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03829410
NCT03829410Phase 2Completed
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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

Cardiff Oncology·interventional·Posted Feb 4, 2019·Updated Mar 4, 2025

In Brief

A Phase 2 clinical trial evaluating Onvansertib, Bevacizumab, and 1 other intervention for Metastatic Colorectal Cancer and KRAS Gene Mutation. Completed, enrolled 68 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer, KRAS Gene Mutation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 4, 2019
Enrollment StartJun 24, 2019
Primary CompletionJan 29, 2024
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 7.4 years ago

Interventions

Onvansertibdrug

Onvansertib orally.

Bevacizumabbiological

Bevacizumab intravenously.

FOLFIRIdrug

FOLFIRI intravenously.