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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
Summary
This trial is testing a new drug called onvansertib combined with standard chemotherapy and bevacizumab for colorectal cancer patients with specific gene mutations who didn't respond to earlier treatment. The new drug aims to block cancer cell growth, making the existing chemotherapy work better. Bevacizumab is used in combination with chemotherapy for treating advanced colorectal cancer.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
Efficacy: Exposure Response Evaluation of Onvansertib
+5 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
~5540
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Colorectal cancer treatments often involve a combination of chemotherapy, targeted therapy, and newer agents like PLK1 inhibitors. Chemotherapy regimens, such as FOLFIRI (fluorouracil, leucovorin, and irinotecan) and FOLFOX (fluorouracil, leucovorin, and oxaliplatin), work by damaging the DNA of rapidly dividing cancer cells, leading to cell death.
Targeted therapies, like bevacizumab, inhibit angiogenesis by blocking the vascular endothelial growth factor (VEGF), thereby starving the tumor of nutrients and oxygen. Onvansertib, a PLK1 inhibitor, disrupts cell division by inhibiting Polo-like kinase 1, a protein crucial for cell cycle progression.
This is particularly important for colorectal cancer patients as these treatments can be tailored based on the genetic profile of the tumor, potentially improving efficacy and reducing side effects.
Exposure to sodium channel-inhibiting drugs and cancer survival: protocol for a cohort study using the QResearch primary care database.Highlights from the 42nd annual meeting of the American Society of Clinical Oncology Atlanta, GA, USA, 2-6 June 2006.The importance of measuring quality of life in phase I/II trials of cancer therapy--the effects of antibody targeted therapy: Part I.
Exposure to sodium channel-inhibiting drugs and cancer survival: protocol for a cohort study using the QResearch primary care database.Highlights from the 42nd annual meeting of the American Society of Clinical Oncology Atlanta, GA, USA, 2-6 June 2006.The importance of measuring quality of life in phase I/II trials of cancer therapy--the effects of antibody targeted therapy: Part I.
Find a Location
Who is running the clinical trial?
Cardiff OncologyLead Sponsor
10 Previous Clinical Trials
606 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
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