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NCT01468623 · ClinicalTrials.gov registry record · Phase 4
Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6
A Phase 4 study, sponsored by Myriad Genetic Laboratories.
- Terminated
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT01468623: Clinical Trial Phase 4 study, sponsored by Myriad Genetic Laboratories.
NCT01468623 is a Phase 4 study that was terminated before completion, run by Myriad Genetic Laboratories. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468623, a Phase 4 study, was terminated before completion, sponsored by Myriad Genetic Laboratories.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU versus standard Body Surface Area (BSA) based administration of 5-FU in patients with metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to BSA dosing response.
Interventions
- OTHER Standard of care
- OTHER Pharmacokinetic 5-FU dose adjustment using OnDose® assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
Why NCT01468623 stopped before completion
NCT01468623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT01468623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468623 about?
NCT01468623 is a clinical study titled "Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6". The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU versus standard Body Surface Area (BSA) based administration of 5-FU in patients with metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine if the use of OnDose® achie...
What is the current status of trial NCT01468623?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2011-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01468623?
The interventions under investigation include: Standard of care (OTHER), Pharmacokinetic 5-FU dose adjustment using OnDose® assay (OTHER).
Who is sponsoring clinical trial NCT01468623?
This trial is sponsored by Myriad Genetic Laboratories, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01468623's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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