Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by United Therapeutics.
NCT01592045 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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 \[NCI\]).
Primary Outcome
Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin
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 |
What the finished NCT01592045 record still lists
NCT01592045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 5 interventions - of which Isotretinoin is the first listed.
NCT01592045 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01592045's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia