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NCT03829410 · ClinicalTrials.gov registry record · Phase 1
Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation
A Phase 1 study, sponsored by Cardiff Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT03829410: Completed Phase 1 study, sponsored by Cardiff Oncology.
NCT03829410 is a Phase 1 study that has completed, run by Cardiff Oncology. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03829410, a Phase 1 study, has completed, sponsored by Cardiff Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily on Day 1-5 and Day 15-19 of each 28-day cycle, in combination with FOLFIRI + Bevacizumab, as second-line treatment in adult participants who have metastatic colorectal cancer with a KRAS mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.
Primary Outcome
DLTs were defined as a Grade 4 hematologic adverse events (AEs), Grade ≥ 3 non-hematologic AEs that were considered related to the study drug and that did not resolve within 14 days following presentation with standard management and care, Grade ≥ 3 thrombocytopenia with bleeding, neutropenic fever, any death not clearly due to the underlying disease or extraneous causes, or any change in liver function that met Hy's Law criteria of a DLT.
Interventions
- BIOLOGICAL Bevacizumab
- DRUG FOLFIRI
- DRUG Onvansertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2024-01-29 |
| Phase | Phase 1 |
What the finished NCT03829410 record still lists
NCT03829410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT03829410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03829410 about?
NCT03829410 is a clinical study titled "Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation". The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily on Day 1-5 and Day 15-19 of each 28-day cycle, in combination with FOLFIRI + Bevacizumab, as second-line treatment in adult participants who have metastatic colorectal cancer with a...
What is the current status of trial NCT03829410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2019-06-24. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT03829410?
The interventions under investigation include: Bevacizumab (BIOLOGICAL), FOLFIRI (DRUG), Onvansertib (DRUG).
Who is sponsoring clinical trial NCT03829410?
This trial is sponsored by Cardiff Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03829410's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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