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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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