The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation for a research study. This study is for patients who have not received prior treatment for their metastatic colorectal cancer. The purpose of the study is to provide evidence that the addition of the investigational agent onvansertib to standard anti-cancer treatment of FOLFIRI or FOLFOX and bevacizumab will improve treatment results. This investigational study will have participants treated with FOLFIRI and bevacizumab or FOLFOX and bevacizumab alone (control arms) or with study treatment onvansertib in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab (investigational arms). Onvansertib is an investigational drug. “Investigational” means this treatment is still being tested and has not been approved by the Food and Drug Administration (FDA) for the condition being studied.
The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening visit to check for eligibility for the study. After the screening visit you will enter the treatment period which starts with the administration of FOLFOX or FOLFIRI with Bevacizumab with or without onvansertib as per study treatment assigned. Study treatments are divided into “study treatment cycles” (each cycle is 4 weeks). If it is decided that you will no longer take study treatment, you will have an “End of Study Treatment” visit which will be done within 28 days of your last study treatment from when your study doctor decides to stop and prior to starting a new anti-cancer treatment. After stopping study treatment, you will be in the Follow-up period. Participants will be followed for up to 1 year after end of study treatment for survival status, new treatments provided and disease assessments. The information will be collected approximately every 8 weeks during the follow-up period.
The study drug, onvansertib, will be provided by the sponsor at no cost to you. All additional study procedures, including laboratory tests, physical examinations, and visits to the study center are provided to you at no charge.
Additional information can be found here: https://clinicaltrials.gov/study/NCT06106308
$65 stipend per visit Hotel Reimbursement: $175 per night