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Brief Title: Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation
Official 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 ID: NCT05593328
Brief Summary: The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil \[5-FU\], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic in Arizona - Phoenix Campus, Phoenix, Arizona, United States
Central Arkansas Radiation Therapy Institute - Cancer Center, Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Anaheim, California, United States
Comprehensive Blood and Cancer Center - Bakersfield, Bakersfield, California, United States
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCI Health - Chao Family Comprehensive Cancer Center, Orange, California, United States
UCLA Health - Santa Monica Parkside Cancer Care, Santa Monica, California, United States
Torrance Memorial Physician Network - Cancer Care and Infusion Center, Torrance, California, United States
PIH Health, Whittier, California, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Memorial Hospital West, Pembroke Pines, Florida, United States
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion, Grand Rapids, Michigan, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine Center for Advanced Medicine, Saint Louis, Missouri, United States
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy, Omaha, Nebraska, United States
Englewood Health, Englewood, New Jersey, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Manhattan Hematology Oncology Associates, New York, New York, United States
Gabrail Cancer and Research Center, Canton, Ohio, United States
Trihealth Kenwood, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
West Cancer Center - East Campus, Germantown, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
University of Virginia School of Medicine, Charlottesville, Virginia, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States