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NCT03332667 · ClinicalTrials.gov registry record · Phase 1
MIBG With Dinutuximab +/- Vorinostat
A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03332667 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 45 participants.
The verdict
NCT03332667, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will utilize a traditional Phase I rolling 6 dose escalation design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients will then be enrolled. If tolerable, vorinostat will then be added to the third dose level. A 6 patient expansion cohort may then be enrolled.
Interventions
- DRUG Vorinostat
- DRUG Sargramostim
- DRUG Dinutuximab
- RADIATION 131I-MIBG
- DRUG Potassium Iodide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2024-02-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03332667
The ClinicalTrials.gov registry entry for NCT03332667 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Vorinostat is the first listed.
NCT03332667 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03332667 about?
NCT03332667 is a clinical study titled "MIBG With Dinutuximab +/- Vorinostat". 131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will uti...
What is the current status of trial NCT03332667?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2018-09-12. Estimated completion is 2024-02-23.
What interventions are being tested in trial NCT03332667?
The interventions under investigation include: Vorinostat (DRUG), Sargramostim (DRUG), Dinutuximab (DRUG), 131I-MIBG (RADIATION), Potassium Iodide (DRUG).
Who is sponsoring clinical trial NCT03332667?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
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