Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Cardiff Oncology
Collaborating Sponsors:
Pfizer
Conditions:
Metastatic Colorectal Cancer
CRC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pharmacodynamic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT06106308
Start Date
February 27 2024
End Date
January 1 2027
Last Update
April 29 2025
Active Locations (41)
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1
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
2
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
St. Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
4
Highlands Oncology Group
Springdale, Arkansas, United States, 72762