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Angiogenesis Inhibitor
Onvansertib + FOLFIRI + Bevacizumab for Colorectal Cancer
Phase 2
Waitlist Available
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 2 years
Awards & highlights
Study Summary
This trial studies two doses of a drug to treat metastatic colorectal cancer in patients who didn't respond to previous treatments.
Who is the study for?
Adults with metastatic colorectal cancer that has progressed after oxaliplatin/fluoropyrimidine-based treatment. They must have KRAS or NRAS mutations, measurable disease via CT/MRI, and good organ function. Not eligible if they've had irinotecan before, brain metastasis, GI absorption issues, certain heart conditions or severe allergies to trial drugs.Check my eligibility
What is being tested?
The trial is testing two doses of Onvansertib in combination with FOLFIRI (irinotecan, fluorouracil [5-FU], leucovorin) and Bevacizumab against just FOLFIRI and Bevacizumab for those who didn't respond well to first-line therapy for their KRAS/NRAS mutated colorectal cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in organs; gastrointestinal disturbances like diarrhea; blood clots; high blood pressure; bleeding risks; fatigue from chemotherapy agents; and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Area Under The Plasma Concentration Curve (AUC) of Onvansertib
Area Under The Plasma Concentration Curve (AUC) of Onvansertib Metabolites
Disease Control Rate (DCR)
+11 moreTrial Design
3Treatment 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 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle.
Group II: Onvansertib 20 mg + Standard of Care (SOC)Experimental Treatment3 Interventions
Participants will receive 20 mg of onvansertib on Days 1 to 5 and 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle.
Group III: Standard of Care (SOC)Active Control2 Interventions
Participants will receive SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
2017
Completed Phase 2
~220
FOLFIRI
2005
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Cardiff OncologyLead Sponsor
10 Previous Clinical Trials
596 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My doctor agrees FOLFIRI therapy is suitable for me.My cancer has specific genetic mutations (KRAS, NRAS, BRAF-V600) or is MSI-H/dMMR.I have had more than one chemotherapy treatment for cancer that has spread.I have not had major surgery in the last 6 weeks.My cancer has a KRAS or NRAS mutation as confirmed by a certified lab.My cancer has worsened despite treatment with specific chemotherapy drugs.I have been treated with oxaliplatin-based chemotherapy, with or without bevacizumab, for at least 6 weeks.I have received treatment for my condition within the last 6 months.I stopped oxaliplatin due to side effects or used it for maintenance, and my disease worsened within 6 months after the last dose.I have never been treated with irinotecan.I have received treatment for my condition within the last 6 months.I have brain metastasis that hasn't been treated or is causing symptoms.I do not have severe GI issues that could affect medication absorption.I cannot or do not want to take pills.I have Gilbert's syndrome.I am not currently using strong medication that affects liver enzymes or can switch to another.My cancer returned or worsened more than 6 months after my last oxaliplatin treatment.I will be taking medications that can affect my heart's rhythm.My organs are functioning well.I haven't had cancer treatment in the last 28 days, except for one radiation dose for pain.My colorectal cancer cannot be removed by surgery and may have spread.I've had a recent scan showing all my cancer areas, using CT or MRI.I have risk factors for heart rhythm problems, like a family history of Long QT Syndrome or low potassium.My heart's electrical cycle is longer than normal, even after checking it multiple times.My cancer has worsened despite treatment with specific chemotherapy drugs.I have previously received oxaliplatin-based chemotherapy for at least 6 weeks.I am 18 years old or older.My colorectal cancer cannot be removed by surgery and has spread.My cancer has a KRAS or NRAS mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Onvansertib 20 mg + Standard of Care (SOC)
- Group 2: Onvansertib 30 mg + Standard of Care (SOC)
- Group 3: Standard of Care (SOC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT05593328 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are research participants being inducted for this experiment?
"Yes, according to information on clinicaltrials.gov the trial is still recruiting participants, having been posted on December 1st 2022 and updated recently in that same month. To complete the study 150 patients need to be recruited from 34 locations."
Answered by AI
What is the greatest amount of participants involved in this investigation?
"To properly conduct this clinical trial, we need 150 qualified candidates. The research is being conducted by collaborating medical centres at the University of California Irvine (UCI) Health in Irvine and Norris Comprehensive Cancer Center in Los Angeles."
Answered by AI
Has the combination of Onvansertib 30 mg + Standard of Care (SOC) been authorized by the FDA?
"Onvansertib 30 mg + Standard of Care (SOC) was assigned a score of 2, as the Phase 2 trial provides evidence that it is safe but not effective."
Answered by AI
Are there numerous venues hosting this research endeavor in the city?
"Numerous medical sites are offering this study such as UCI Health in Irvine, Norris Comprehensive Cancer Center in Los Angeles, and Washington University School of Medicine's Centre for Advanced Medicine based out of Saint Louis. A full list containing 34 locations can be found online."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic in Arizona - Phoenix Campus
Mayo Clinic - Rochester
Northwestern University
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
- It targets KRAS mutations, which is detected in my case, and seems like isn't the dominating/driving mutation at the moment.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- Norris Comprehensive Cancer Center: < 48 hours
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