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NCT02014558 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 265
- Enrollment target
NCT02014558 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 265 participants.
The verdict
NCT02014558, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 265 participants
- Enrollment target
Study Summary
The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML). This study also determined the pharmacokinetic (PK) parameters of gilteritinib.
Interventions
- DRUG Midazolam
- DRUG Gilteritinib
- DRUG Cephalexin
- DRUG Voriconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2013-10-09 |
| Est. Completion | 2018-03-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02014558
The ClinicalTrials.gov registry entry for NCT02014558 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT02014558 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02014558 about?
NCT02014558 is a clinical study titled "Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia". The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML). This study also determined the pharmacokinetic (PK) parameters of gilteritinib.
What is the current status of trial NCT02014558?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 265 participants. The study started on 2013-10-09. Estimated completion is 2018-03-07.
What interventions are being tested in trial NCT02014558?
The interventions under investigation include: Midazolam (DRUG), Gilteritinib (DRUG), Cephalexin (DRUG), Voriconazole (DRUG).
Who is sponsoring clinical trial NCT02014558?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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