Phase
Condition
Colorectal Cancer
Metastatic Cancer
Treatment
FOLFIRI
Bevacizumab
Onvansertib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed metastatic colorectal cancer.
Documented KRAS or NRAS mutation.
No previous systemic therapy in the metastatic setting.
Participants must be willing to submit archival tissue or undergo fresh biopsy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Women of childbearing potential must use contraception or take measures to avoidpregnancy.
Imaging computed tomography (CT) or magnetic resonance imaging (MRI) ofchest/abdomen/pelvis and other scans as necessary to document all sites of diseaseperformed within 28 days prior to the first dose of onvansertib.
Must have acceptable organ function
Exclusion
Exclusion Criteria:
Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instabilityhigh/deficient mismatch repair.
Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
Previous oxaliplatin treatment within 12 months prior to randomization, when armopen.
Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Anticancer chemotherapy or biologic therapy administered within 28 days prior to thefirst dose of study drug.
Untreated or symptomatic brain metastasis.
Gastrointestinal (GI) disorder(s) that would significantly impede the absorption ofan oral agent.
Unable or unwilling to swallow study drug.
Uncontrolled intercurrent illness.
Known hypersensitivity to fluoropyrimidine or leucovorin, irinotecan, or oxalipatin.
Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers.
QTc >470
Study Design
Connect with a study center
Mayo Clinic - Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
The University of Arizona Cancer Center
Tucson, Arizona 85724
United StatesSite Not Available
St. Bernards Medical Center
Jonesboro, Arkansas 72401
United StatesSite Not Available
Highlands Oncology Group
Springdale, Arkansas 72762
United StatesSite Not Available
Pacific Cancer Medical Center
Anaheim, California 92801
United StatesSite Not Available
Comprehensive Blood and Cancer Center - Bakersfield
Bakersfield, California 93309
United StatesSite Not Available
Orange Coast Memorial Medical Center
Fountain Valley, California 92708
United StatesSite Not Available
UC San Diego Moores Cancer Center
La Jolla, California 92037
United StatesSite Not Available
Norris Comprehensive Cancer Center
Los Angeles, California 90089
United StatesSite Not Available
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California 90095
United StatesSite Not Available
Sharp Memorial Hospital
San Diego, California 92123
United StatesSite Not Available
Torrance Memorial Physician Network - Cancer Care and Infusion Center
Torrance, California 90505
United StatesSite Not Available
PIH Health
Whittier, California 90602
United StatesSite Not Available
Memorial Cancer Institute
Hollywood, Florida 33021
United StatesSite Not Available
Mayo Clinic - Florida
Jacksonville, Florida 32224
United StatesSite Not Available
Cleveland Clinic Martin Health
Stuart, Florida 34994
United StatesSite Not Available
Kaiser Permanente
Honolulu, Hawaii 96819
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United StatesSite Not Available
The University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
United StatesSite Not Available
Cancer Center of Kansas
Wichita, Kansas 67214
United StatesSite Not Available
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan 49503
United StatesSite Not Available
Mayo Clinic Cancer Center
Rochester, Minnesota 55905
United StatesSite Not Available
Saint Luke's Hospital
Kansas City, Missouri 64111
United StatesSite Not Available
Washington University School of Medicine Center for Advanced Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
CCCN
Las Vegas, Nevada 89119
United StatesSite Not Available
Manhattan Hematology Oncology (MHO) Research Foundation, Inc.
New York, New York 10016
United StatesSite Not Available
Trihealth Kenwood
Cincinnati, Ohio 45242
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United StatesSite Not Available
West Cancer Clinic
Germantown, Tennessee 38138
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Oncology Consultants, PA
Houston, Texas 77024
United StatesSite Not Available
Utah Cancer Specialists
Salt Lake City, Utah 84124
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United StatesSite Not Available
VCU Massey Cancer Center
Richmond, Virginia 23298
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
United StatesSite Not Available
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