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NCT01169012 · ClinicalTrials.gov registry record · Phase 1
PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01169012: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT01169012 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01169012, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a non-blinded, non-randomized pharmacokinetic study to determine the oral bioavailability of clofarabine, and the effect of cimetidine on clofarabine pharmacokinetics in patients with poor-risk acute leukemias and myelodysplastic syndrome (MDS).
Primary Outcome
Regarding primary endpoints, each patient will generate pharmacokinetic data sufficient to compute area under the concentration versus time curve (AUC) and clearance (Cl) for each of the initial three clofarabine doses (IV, PO and IV administered after cimetidine) for each patient. These values will be used to compute the human oral bioavailability of clofarabine and compare AUC and Cl of clofarabine when given after cimetidine with AUC and Cl of clofarabine when administered alone
Interventions
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT01169012 record still lists
NCT01169012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Clofarabine is the first listed.
NCT01169012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01169012 about?
NCT01169012 is a clinical study titled "PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias". This is a non-blinded, non-randomized pharmacokinetic study to determine the oral bioavailability of clofarabine, and the effect of cimetidine on clofarabine pharmacokinetics in patients with poor-risk acute leukemias and myelodysplastic syndrome (MDS).
What is the current status of trial NCT01169012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2010-09. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01169012?
The interventions under investigation include: Clofarabine (DRUG).
Who is sponsoring clinical trial NCT01169012?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01169012's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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