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Protein Kinase Inhibitor

Onvansertib + Chemotherapy for Colorectal Cancer

Phase 2
Recruiting
Research Sponsored by Cardiff Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights

Summary

This trial aims to determine the most effective dose of onvansertib and evaluate its safety and effectiveness when combined with certain chemotherapy regimens in patients with a specific type of colorectal cancer that has

Who is the study for?
This trial is for adults with metastatic colorectal cancer that has specific mutations (KRAS or NRAS). They should not have had previous systemic therapy for their metastatic condition, must be able to undergo scans to document the disease, and agree to provide tissue samples. Participants need to be relatively active and healthy (ECOG status 0 or 1) and take steps to prevent pregnancy.
What is being tested?
The study is testing two different doses of a drug called Onvansertib in combination with standard chemotherapy regimens FOLFIRI or FOLFOX, both also paired with Bevacizumab. The goal is to find the lowest effective dose of Onvansertib and evaluate its safety and effectiveness against metastatic colorectal cancer.
What are the potential side effects?
Potential side effects may include those common with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to lowered white blood cell counts; plus any additional effects from Onvansertib which will be studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
Number of Participants with an Adverse Event (AE)
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Onvansertib 30 mg + Standard of Care (SOC)Experimental Treatment3 Interventions
Participants will receive 30 mg of onvansertib + on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI on Day 1 and Day 15 of each 28-day treatment cycle.
Group II: Onvansertib 30 mg + Standard of CareExperimental Treatment3 Interventions
Participants will receive 30 mg onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle.
Group III: Onvansertib 20mg + Standard of CareExperimental Treatment3 Interventions
Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI/BEV on Day 1 and Day 15 of each 28-day treatment cycle.
Group IV: Onvansertib 20 mg + Standard of CareExperimental Treatment3 Interventions
Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle.
Group V: Standard of CareActive Control2 Interventions
Participants will receive FOLFOX/Bev on Day 1 and Day 15 of each 28-day treatment cycle.
Group VI: Standard of Care (SOC)Active Control2 Interventions
Participants will receive FOLFIRI/Bev on Day 1 and Day 15 of each 28-day treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFOX
2009
Completed Phase 3
~4560
Bevacizumab
2013
Completed Phase 4
~5540
Onvansertib
2017
Completed Phase 2
~220
FOLFIRI
2005
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,638 Previous Clinical Trials
17,738,960 Total Patients Enrolled
Cardiff OncologyLead Sponsor
10 Previous Clinical Trials
539 Total Patients Enrolled
~60 spots leftby Nov 2026
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