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NCT00001565 · ClinicalTrials.gov registry record · Phase 1
Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Refractory Malignancy
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00001565: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001565 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001565, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a pharmacokinetic trial. Patients receive phenylbutyrate through a central venous catheter for each 28 day cycle. The first several days of drug administration should be inpatient. Cycles may be repeated if there is no tumor progression or dose limiting toxicities (DLT). There are no breaks between cycles. Once a minimum of 3 patients have completed at least 4 weeks of therapy without DLT, new patients will be entered at the next dose level.
Interventions
- DRUG phenylbutyrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 1996-12 |
| Est. Completion | 2000-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001565
The ClinicalTrials.gov registry entry for NCT00001565 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which phenylbutyrate is the first listed.
NCT00001565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001565 about?
NCT00001565 is a clinical study titled "Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Refractory Malignancy". This is a pharmacokinetic trial. Patients receive phenylbutyrate through a central venous catheter for each 28 day cycle. The first several days of drug administration should be inpatient. Cycles may be repeated if there is no tumor progression or dose limiting toxicities (DLT). There are no breaks ...
What is the current status of trial NCT00001565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 1996-12. Estimated completion is 2000-10.
What interventions are being tested in trial NCT00001565?
The interventions under investigation include: phenylbutyrate (DRUG).
Who is sponsoring clinical trial NCT00001565?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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