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NCT02390544 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Melphalan in Children
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT02390544 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 34 participants.
The verdict
NCT02390544, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the pharmacokinetics (PK) of melphalan in children undergoing hematopoietic stem cell transplantation (HSCT). Melphalan is an important component of HSCT preparative regimens, but can be associated with significant toxicity. PK data is a powerful clinical tool that, when used to develop individualized treatment plans for a specific patient, may ultimately increase the likelihood of selecting the right dose for the right patient and/or of reducing the number of adverse drug events. The investigators' goal is to establish baseline pediatric melphalan PK data. These data may be used for patient specific dosing of melphalan in the future to minimize toxicity and improve transplant outcomes.
Interventions
- DRUG Melphalan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2015-05-08 |
| Est. Completion | 2018-09-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02390544
The ClinicalTrials.gov registry entry for NCT02390544 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Melphalan is the first listed.
NCT02390544 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02390544 about?
NCT02390544 is a clinical study titled "A Pharmacokinetic Study of Melphalan in Children". The purpose of this study is to examine the pharmacokinetics (PK) of melphalan in children undergoing hematopoietic stem cell transplantation (HSCT). Melphalan is an important component of HSCT preparative regimens, but can be associated with significant toxicity. PK data is a powerful clinical tool...
What is the current status of trial NCT02390544?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2015-05-08. Estimated completion is 2018-09-23.
What interventions are being tested in trial NCT02390544?
The interventions under investigation include: Melphalan (DRUG).
Who is sponsoring clinical trial NCT02390544?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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