What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as the FOLFIRI regimen (irinotecan, fluorouracil, and leucovorin) combined with bevacizumab, often result in side effects including diarrhea, nausea, vomiting, fatigue, and neutropenia. Bevacizumab, an anti-VEGF monoclonal antibody, can cause hypertension, proteinuria, and increased risk of bleeding and thromboembolic events. These side effects are important considerations for patients undergoing these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that are similar to the regimen being studied with Onvansertib. Notably, the combination of FOLFIRI (irinotecan, fluorouracil, leucovorin) with bevacizumab, an anti-VEGF monoclonal antibody, is a well-established treatment for metastatic colorectal cancer. Bevacizumab was first approved by the FDA in 2004 for use in combination with intravenous 5-fluorouracil-based chemotherapy for first-line treatment of metastatic colorectal cancer. This combination aims to inhibit angiogenesis and tumor growth, providing a foundation for further studies involving additional agents like Onvansertib.

What other types of research exist?

Promising novel alternatives to Onvansertib for colorectal cancer patients include: <ol> <li>Bevacizumab: An anti-VEGF monoclonal antibody that has shown activity in advanced colorectal cancer.</li> <li></li> </ol> Panitumumab: An anti-EGFR antibody that has demonstrated efficacy in combination with chemotherapy. 3. Lenvatinib: A tyrosine kinase inhibitor with modest antitumor activity in gastrointestinal neuroendocrine tumors, which may be applicable to colorectal cancer. 4. Cabozantinib: Currently being evaluated in a phase III trial for advanced neuroendocrine tumors, including colorectal cancer. 5. Pembrolizumab: An immune checkpoint inhibitor that has shown promise in various solid tumors, including colorectal cancer.

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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Do I qualify?Apply below to find out

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.