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Protein Kinase Inhibitor

Onvansertib 20 mg + Standard of Care 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Area Under the Plasma Concentration Curve (AUC) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab

Disease Control Rate (DCR)

Duration of Response (DOR)

+8 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

~5280

Onvansertib

2017

Completed Phase 2

~220

FOLFIRI

2005

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,892 Total Patients Enrolled

Cardiff OncologyLead Sponsor

10 Previous Clinical Trials

529 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of Onvansertib 30 mg with Standard of Care been granted approval by the FDA?

"According to our assessment at Power, the safety rating for Onvansertib 30 mg + Standard of Care is a 2 on a scale from 1 to 3. This score corresponds with being in Phase 2 of the trial and indicates some existing safety data without evidence supporting effectiveness."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Per clinicaltrials.gov, recruitment for this trial is currently closed. The trial was first listed on 11/16/2023 and last updated on 10/24/2023. Despite this particular study no longer accepting patients, there are a total of 954 other trials actively seeking participants at present."

Answered by AI