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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: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT02014558 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 265 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (342% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2)
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 |
What the finished NCT02014558 record still lists
NCT02014558 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (342% higher).
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT02014558 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02014558's enrollment target sits among peer trials
265 154th of 2000 higher than 1,844 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
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