A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation

UVA Tracking #
HSR220443
Principal Investigator
Matthew J Reilley
Contact
Contact Phone
Official Trial Title
A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Metastatic Colorectal Cancer with a KRAS or NRAS Mutation to participate in a research study. The study will evaluate if the addition of the investigational agent onvansertib to standard anti-cancer treatment of FOLFIRI and bevacizumab will improve results in treating your type of cancer. Onvansertib is considered an investigational drug for use in this study because it has not been approved by the FDA. This investigational study will have subjects treated with FOLFIRI and bevacizumab alone (control arm) or with onvansertib in combination with FOLFIRI and bevacizumab (investigational arm).

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, talking to the study doctor, and answering questionnaires. Participation includes a screening visit, 2 visits per cycle during treatment (3 visits in cycle 1), and end of study treatment visit, and a follow-up period via phone calls to keep track of how you are doing. Treatment cycles for this study are 28 days. You may continue on study treatment as long as you are tolerating it and as long as your cancer is not worsening.

The investigational drug onvansertib, as well as study related doctor's visits and laboratory tests, will be provided at no cost to you.

More information about this study can be found at https://clinicaltrials.gov/ct2/show/NCT05593328?term=crdf-003&draw=2&ra…

uvacancertrials@hscmail.mcc.virginia.edu

Reimbursement - $65 per visit
Hotel Reimbursement – up to $175

Compensation

$65 per visit