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NCT02676323 · ClinicalTrials.gov registry record · Phase 1
Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02676323 is a Phase 1 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 19 participants.
The verdict
NCT02676323, a Phase 1 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs called "histone deacetylase (HDAC) inhibitors." HDAC inhibitors like panobinostat block enzymes known as histone deacetylases, which stops cancer cells from dividing and causes them to die. Fludarabine and cytarabine are chemotherapy drugs that are commonly used to treat pediatric patients with refractory or relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The purpose of this study is to test the safety of panobinostat and to find the highest dose of panobinostat that can be given safely when it is combined with fludarabine and cytarabine. This pilot study will be done in two parts: The goal of Part 1 of the study is to find the highest tolerable dose of panobinostat that can be given to patients with AML or MDS, when it is combined with fludarabine and cytarabine. Once that dose is determined, participants will be enrolled on Part 2: Dose Expansion, to look at the effect of the panobinostat/fludarabine/cytarabine combination in patients with leukemia/MDS. PRIMARY OBJECTIVE: * Determine a tolerable dose of panobinostat when given in combination with fludarabine and cytarabine in pediatric patients with relapsed or refractory AML or MDS. SECONDARY OBJECTIVES: * Characterize the pharmacokinetics of panobinostat after the first dose and at steady-state. * Estimate the overall response rate to the combination of panobinostat, fludarabine, and cytarabine.
Interventions
- DRUG Fludarabine
- DRUG Leucovorin
- DRUG Cytarabine
- DRUG Panobinostat
- DRUG Intrathecal Triples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2016-05-03 |
| Est. Completion | 2018-04-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02676323
The ClinicalTrials.gov registry entry for NCT02676323 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT02676323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02676323 about?
NCT02676323 is a clinical study titled "Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome". Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs called "histone deacetylase (HDAC) inhibitors." HDAC inhibitors like panobinostat block enzymes known as histone deacetylases...
What is the current status of trial NCT02676323?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2016-05-03. Estimated completion is 2018-04-09.
What interventions are being tested in trial NCT02676323?
The interventions under investigation include: Fludarabine (DRUG), Leucovorin (DRUG), Cytarabine (DRUG), Panobinostat (DRUG), Intrathecal Triples (DRUG).
Who is sponsoring clinical trial NCT02676323?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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