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Clinical Trials in the USA / NCT06106308
Active, not recruiting Phase 2

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

NCT06106308 · tracked via the Priya Life Science USA tracker
Sponsor
Cardiff Oncology
Phase
Phase 2
Started
2024-02-27
Last updated
2026-06-16

Condition(s) studied

Metastatic Colorectal CancerCRCKRAS/NRAS Mutation

Investigational drug(s) / intervention(s)

OnvansertibFOLFIRIBevacizumabFOLFOX

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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: * Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instability high/deficient mismatch repair. * 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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Mayo Clinic - Arizona Phoenix Arizona
The University of Arizona Cancer Center Tucson Arizona
St. Bernards Medical Center Jonesboro Arkansas
Highlands Oncology Group Springdale Arkansas
Pacific Cancer Medical Center Anaheim California
Comprehensive Blood and Cancer Center - Bakersfield Bakersfield California
Orange Coast Memorial Medical Center Fountain Valley California
UC San Diego Moores Cancer Center La Jolla California
Norris Comprehensive Cancer Center Los Angeles California
UCLA Department of Medicine-Hematology/Oncology Los Angeles California
Sharp Memorial Hospital San Diego California
Torrance Memorial Physician Network - Cancer Care and Infusion Center Torrance California
PIH Health Whittier California
Memorial Cancer Institute Hollywood Florida
Mayo Clinic - Florida Jacksonville Florida
Cleveland Clinic Martin Health Stuart Florida
Kaiser Permanente Honolulu Hawaii
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
The University of Kansas Cancer Center - Westwood Westwood Kansas
Cancer Center of Kansas Wichita Kansas
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion Grand Rapids Michigan
Mayo Clinic Cancer Center Rochester Minnesota
Saint Luke's Hospital Kansas City Missouri
Washington University School of Medicine Center for Advanced Medicine St Louis Missouri
CCCN Las Vegas Nevada
Manhattan Hematology Oncology (MHO) Research Foundation, Inc. New York New York
Trihealth Kenwood Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
Cleveland Clinic Cleveland Ohio
The Ohio State University Wexner Medical Center Columbus Ohio
Oregon Health and Science University Portland Oregon
Lehigh Valley Health Network Allentown Pennsylvania
West Cancer Clinic Germantown Tennessee
Oncology Consultants, PA Houston Texas
MD Anderson Cancer Center Houston Texas
Utah Cancer Specialists Salt Lake City Utah
University of Virginia Charlottesville Virginia
Inova Schar Cancer Institute Fairfax Virginia
VCU Massey Cancer Center Richmond Virginia
Virginia Mason Medical Center Seattle Washington

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06106308 on ClinicalTrials.gov ↗ ← All trials in the USA