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
NCT ID: NCT06106308
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
113 participants
INTERVENTIONAL
2024-02-27
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Onvansertib 20mg + Standard of Care
Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI/BEV on Day 1 and Day 15 of each 28-day treatment cycle.
Onvansertib
Oral capsule
FOLFIRI
FOLFIRI (irinotecan + fluorouracil \[5-FU\] + leucovorin) as intravenous (IV) infusion
Bevacizumab
IV Infusion
Onvansertib 30 mg + Standard of Care (SOC)
Participants will receive 30 mg of onvansertib + on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFIRI on Day 1 and Day 15 of each 28-day treatment cycle.
Onvansertib
Oral capsule
FOLFIRI
FOLFIRI (irinotecan + fluorouracil \[5-FU\] + leucovorin) as intravenous (IV) infusion
Bevacizumab
IV Infusion
Standard of Care (SOC)
Participants will receive FOLFIRI/Bev on Day 1 and Day 15 of each 28-day treatment cycle.
FOLFIRI
FOLFIRI (irinotecan + fluorouracil \[5-FU\] + leucovorin) as intravenous (IV) infusion
Bevacizumab
IV Infusion
Onvansertib 20 mg + Standard of Care
Participants will receive 20 mg of onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle.
Onvansertib
Oral capsule
Bevacizumab
IV Infusion
FOLFOX
FOLFOX (leucovorin + fluorouracil \[5-FU\] + oxaliplatin) as intravenous (IV) infusion
Onvansertib 30 mg + Standard of Care
Participants will receive 30 mg onvansertib on Days 1 to 5 and Days 15 to 19 of each 28-day treatment cycle + FOLFOX on Day 1 and Day 15 of each 28-day treatment cycle.
Onvansertib
Oral capsule
Bevacizumab
IV Infusion
FOLFOX
FOLFOX (leucovorin + fluorouracil \[5-FU\] + oxaliplatin) as intravenous (IV) infusion
Standard of Care
Participants will receive FOLFOX/Bev on Day 1 and Day 15 of each 28-day treatment cycle.
Bevacizumab
IV Infusion
FOLFOX
FOLFOX (leucovorin + fluorouracil \[5-FU\] + oxaliplatin) as intravenous (IV) infusion
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 avoid pregnancy.
* Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis and other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib.
* Must have acceptable organ function
Exclusion Criteria
* Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
* Previous oxaliplatin treatment within 12 months prior to randomization, when arm open.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Anticancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug.
* Untreated or symptomatic brain metastasis.
* Gastrointestinal (GI) disorder(s) that would significantly impede the absorption of an 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Cardiff Oncology
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Ahn DH, Ridinger M, Cannon TL, Mendelsohn L, Starr JS, Hubbard JM, Kasi A, Barzi A, Samuelsz E, Karki A, Subramanian RA, Yemane D, Kim R, Wu CC, Croucher PJP, Smeal T, Kabbinavar FF, Lenz HJ. Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial. J Clin Oncol. 2025 Mar;43(7):840-851. doi: 10.1200/JCO-24-01266. Epub 2024 Oct 30.
Other Identifiers
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CRDF-004
Identifier Type: -
Identifier Source: org_study_id
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