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NCT05593328 · ClinicalTrials.gov registry record · Phase 2

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation

A Phase 2 study, sponsored by Cardiff Oncology.

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT05593328: Completed Phase 2 study, sponsored by Cardiff Oncology.

NCT05593328 is a Phase 2 study that has completed, run by Cardiff Oncology. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05593328, a Phase 2 study, has completed, sponsored by Cardiff Oncology.

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil \[5-FU\], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.

Primary Outcome

Defined as complete response (CR) or partial response (PR) as determined according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by an independent central review.

Interventions

  • DRUG Bevacizumab
  • DRUG FOLFIRI
  • DRUG Onvansertib

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2023-03-17
Est. Completion 2024-12-09
Phase Phase 2
Cardiff Oncology

6 total trials

What the finished NCT05593328 record still lists

NCT05593328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.

NCT05593328 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05593328 about?

NCT05593328 is a clinical study titled "Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation". The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil \[5-FU\], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC...

What is the current status of trial NCT05593328?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2023-03-17. Estimated completion is 2024-12-09.

What interventions are being tested in trial NCT05593328?

The interventions under investigation include: Bevacizumab (DRUG), FOLFIRI (DRUG), Onvansertib (DRUG).

Who is sponsoring clinical trial NCT05593328?

This trial is sponsored by Cardiff Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05593328's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT05593328, the US trial registry maintained by the National Library of Medicine. NCT05593328 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.