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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 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 13 participants.
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).
Interventions
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01169012
The ClinicalTrials.gov registry entry for NCT01169012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Clofarabine is the first listed.
NCT01169012 reports 0 study locations.
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.
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