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NCT01479348 · ClinicalTrials.gov registry record · Early Phase 1
Imaging Study for FdCyd and THU Cancer Treatment
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT01479348: Clinical Trial Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01479348 is a Early Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01479348, a Early Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: \- The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the drug reacts with the cancer. This study is not a treatment study. It is open only to people who are already on the FdCyd and THU cancer treatment study. Objectives: \- To study how FdCyd affects advanced cancer cells. Eligibility: \- Participants in National Cancer Institute study 09-C-0214. Design: * Participants will have two imaging studies, one before starting FdCyd and THU treatment and one after starting treatment. * Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The doses will be followed by two imaging study scans and frequent blood samples. * This procedure will be repeated at a later date, during the FdCyd and THU treatment period. * Treatment will not be provided as part of this study. This is an imaging study protocol only....
Primary Outcome
\[F-18\]-5-fluoro-2'-deoxycytidine (FdCyd) was administered intravenously with administration of tetrahydrouridine (THU) and the frequency and severity of adverse events was observed. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or
Interventions
- DRUG [F-18]-5-FLUORO-2'-DEOXYCYTIDINE
- DRUG Tetrahydrouridine intravenous (IV)
- DRUG Tetrahydrouridine (oral)
- DIAGNOSTIC_TEST Positron emission tomography (PET)/Computed tomography (CT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-11-01 |
| Est. Completion | 2019-01-11 |
| Phase | Early Phase 1 |
Why NCT01479348 stopped before completion
NCT01479348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 4 interventions - of which [F-18]-5-FLUORO-2'-DEOXYCYTIDINE is the first listed.
NCT01479348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01479348 about?
NCT01479348 is a clinical study titled "Imaging Study for FdCyd and THU Cancer Treatment". Background: \- The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the ...
What is the current status of trial NCT01479348?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2011-11-01. Estimated completion is 2019-01-11.
What interventions are being tested in trial NCT01479348?
The interventions under investigation include: [F-18]-5-FLUORO-2'-DEOXYCYTIDINE (DRUG), Tetrahydrouridine intravenous (IV) (DRUG), Tetrahydrouridine (oral) (DRUG), Positron emission tomography (PET)/Computed tomography (CT) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT01479348?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01479348's enrollment target sits among peer trials
5 1887th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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