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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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Bevacizumab
  • DRUG FOLFIRI
  • DRUG FOLFOX
  • DRUG Onvansertib

Study Locations (20)

California

  • Pacific Cancer Medical Center — Anaheim
  • Comprehensive Blood and Cancer Center - Bakersfield — Bakersfield
  • Orange Coast Memorial Medical Center — Fountain Valley
  • UC San Diego Moores Cancer Center — La Jolla
  • Norris Comprehensive Cancer Center — Los Angeles
  • UCLA Department of Medicine-Hematology/Oncology — Los Angeles
  • Sharp Memorial Hospital — San Diego
  • Torrance Memorial Physician Network - Cancer Care and Infusion Center — Torrance
  • PIH Health — Whittier

Florida

  • Memorial Cancer Institute — Hollywood
  • Mayo Clinic - Florida — Jacksonville
  • Cleveland Clinic Martin Health — Stuart

Arizona

  • Mayo Clinic - Arizona — Phoenix
  • The University of Arizona Cancer Center — Tucson

Arkansas

  • St. Bernards Medical Center — Jonesboro
  • Highlands Oncology Group — Springdale

Kansas

  • The University of Kansas Cancer Center - Westwood — Westwood
  • Cancer Center of Kansas — Wichita

Hawaii

  • Kaiser Permanente — Honolulu

Indiana

  • Fort Wayne Medical Oncology and Hematology — Fort Wayne

Trial Details

FieldValue
Enrollment Target 113 participants
Start Date 2024-02-27
Est. Completion 2027-01
Phase Phase 2

Sponsor

Cardiff Oncology

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06106308

The ClinicalTrials.gov registry entry for NCT06106308 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardiff Oncology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06106308 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06106308 about?

NCT06106308 is a clinical study titled "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". 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 ...

What is the current status of trial NCT06106308?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2024-02-27. Estimated completion is 2027-01.

What conditions does trial NCT06106308 study?

This clinical trial studies the following conditions: Metastatic Colorectal Cancer, CRC, KRAS/NRAS Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06106308?

The interventions under investigation include: Bevacizumab (DRUG), FOLFIRI (DRUG), FOLFOX (DRUG), Onvansertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06106308?

This trial is sponsored by Cardiff Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06106308 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial