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NCT06106308 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Metastatic Colorectal Cancer and CRC, sponsored by Cardiff Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
- 20
- Study locations
NCT06106308: Active Phase 2 study of Metastatic Colorectal Cancer and CRC, sponsored by Cardiff Oncology.
NCT06106308 is a Phase 2 study of Metastatic Colorectal Cancer and CRC that is active but no longer recruiting, run by Cardiff Oncology. The registered enrollment target is 113 participants, below the 184-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06106308, a Phase 2 study of Metastatic Colorectal Cancer and CRC, is active but no longer recruiting, sponsored by Cardiff Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause, as determined by blinded independent central review.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT06106308 still lists
NCT06106308 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 184-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (39% lower).
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.
NCT06106308 names 20 study sites across 7 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT06106308?
The interventions under investigation include: Bevacizumab (DRUG), FOLFIRI (DRUG), FOLFOX (DRUG), Onvansertib (DRUG).
Who is sponsoring clinical trial NCT06106308?
This trial is sponsored by Cardiff Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06106308's enrollment target sits among peer trials
113 21st of 45 higher than 25 of 45 other Metastatic Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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