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NCT01592045 · ClinicalTrials.gov registry record · Phase 1
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
A Phase 1 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01592045 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 28 participants.
The verdict
NCT01592045, a Phase 1 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).
Interventions
- DRUG Isotretinoin
- BIOLOGICAL Aldesleukin (IL-2)
- BIOLOGICAL ch14.18 -NCI
- BIOLOGICAL ch14.18-UTC
- BIOLOGICAL Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01592045
The ClinicalTrials.gov registry entry for NCT01592045 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Isotretinoin is the first listed.
NCT01592045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01592045 about?
NCT01592045 is a clinical study titled "ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma". The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).
What is the current status of trial NCT01592045?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2012-08. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01592045?
The interventions under investigation include: Isotretinoin (DRUG), Aldesleukin (IL-2) (BIOLOGICAL), ch14.18 -NCI (BIOLOGICAL), ch14.18-UTC (BIOLOGICAL), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01592045?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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