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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
Sponsor: Cardiff Oncology
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.
Official title: A Phase 2, Randomized, Open-label 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 Patients With a KRAS or NRAS Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2024-02-27
Completion Date
2027-01
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
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
Locations (41)
Mayo Clinic - Arizona
Phoenix, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
St. Bernards Medical Center
Jonesboro, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Pacific Cancer Medical Center
Anaheim, California, United States
Comprehensive Blood and Cancer Center - Bakersfield
Bakersfield, California, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Torrance Memorial Physician Network - Cancer Care and Infusion Center
Torrance, California, United States
PIH Health
Whittier, California, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Cleveland Clinic Martin Health
Stuart, Florida, United States
Kaiser Permanente
Honolulu, Hawaii, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Washington University School of Medicine Center for Advanced Medicine
St Louis, Missouri, United States
CCCN
Las Vegas, Nevada, United States
Manhattan Hematology Oncology (MHO) Research Foundation, Inc.
New York, New York, United States
Trihealth Kenwood
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
West Cancer Clinic
Germantown, Tennessee, United States
Oncology Consultants, PA
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States