Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
Onvansertib: Oral capsule
FOLFIRI: FOLFIRI (irinotecan + fluorouracil \[5-FU\] + leucovorin) as intravenous (IV) infusion
Bevacizumab: IV Infusion
FOLFOX: FOLFOX (leucovorin + fluorouracil \[5-FU\] + oxaliplatin) as intravenous (IV) infusion
Study summary
The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) — Up to approximately 1 year
ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause, as determined by blinded independent central review.
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic - Arizona | Phoenix | Arizona | |
| The University of Arizona Cancer Center | Tucson | Arizona | |
| St. Bernards Medical Center | Jonesboro | Arkansas | |
| Highlands Oncology Group | Springdale | Arkansas | |
| Pacific Cancer Medical Center | Anaheim | California | |
| Comprehensive Blood and Cancer Center - Bakersfield | Bakersfield | California | |
| Orange Coast Memorial Medical Center | Fountain Valley | California | |
| UC San Diego Moores Cancer Center | La Jolla | California | |
| Norris Comprehensive Cancer Center | Los Angeles | California | |
| UCLA Department of Medicine-Hematology/Oncology | Los Angeles | California | |
| Sharp Memorial Hospital | San Diego | California | |
| Torrance Memorial Physician Network - Cancer Care and Infusion Center | Torrance | California | |
| PIH Health | Whittier | California | |
| Memorial Cancer Institute | Hollywood | Florida | |
| Mayo Clinic - Florida | Jacksonville | Florida | |
| Cleveland Clinic Martin Health | Stuart | Florida | |
| Kaiser Permanente | Honolulu | Hawaii | |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | |
| The University of Kansas Cancer Center - Westwood | Westwood | Kansas | |
| Cancer Center of Kansas | Wichita | Kansas | |
| Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion | Grand Rapids | Michigan | |
| Mayo Clinic Cancer Center | Rochester | Minnesota | |
| Saint Luke's Hospital | Kansas City | Missouri | |
| Washington University School of Medicine Center for Advanced Medicine | St Louis | Missouri | |
| CCCN | Las Vegas | Nevada | |
| Manhattan Hematology Oncology (MHO) Research Foundation, Inc. | New York | New York | |
| Trihealth Kenwood | Cincinnati | Ohio | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| Cleveland Clinic | Cleveland | Ohio | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| Oregon Health and Science University | Portland | Oregon | |
| Lehigh Valley Health Network | Allentown | Pennsylvania | |
| West Cancer Clinic | Germantown | Tennessee | |
| Oncology Consultants, PA | Houston | Texas | |
| MD Anderson Cancer Center | Houston | Texas | |
| Utah Cancer Specialists | Salt Lake City | Utah | |
| University of Virginia | Charlottesville | Virginia | |
| Inova Schar Cancer Institute | Fairfax | Virginia | |
| VCU Massey Cancer Center | Richmond | Virginia | |
| Virginia Mason Medical Center | Seattle | Washington |
+ 1 more sites — see the full list on the official registry below.
On this site
📄 Avastin (bevacizumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06106308 on ClinicalTrials.gov ↗ ← All trials in the USA