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NCT04079296 · ClinicalTrials.gov registry record · Phase 1
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT04079296: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04079296 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04079296, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517. This study also evaluated the clinical response of ASP7517 as well as other measures of anticancer activity of ASP7517.
Primary Outcome
DLT was defined as any of the following events that occurred within 28 days starting with the first dose on cycle 1 day 1 (C1D1) and that was considered to be related to study drug. DLT was defined as follows: * Grade 3 of more : non-hematologic AEs that are ≥ grade 3 * Confirmed Hy's law case * New onset of grade 4 thrombocytopenia (with minimum of 2 grade worsening from baseline) within 24 hours of dosing * Prolonged myelosuppression, defined as absolute neutrophil count (ANC) \< 500/microlit
Interventions
- BIOLOGICAL ASP7517
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2023-04-21 |
| Phase | Phase 1 |
What the finished NCT04079296 record still lists
NCT04079296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which ASP7517 is the first listed.
NCT04079296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04079296 about?
NCT04079296 is a clinical study titled "A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)". The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517. This study also evaluated the clinical response of ASP7517 as well as other measures of anticancer activity of ASP7517.
What is the current status of trial NCT04079296?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-09-19. Estimated completion is 2023-04-21.
What interventions are being tested in trial NCT04079296?
The interventions under investigation include: ASP7517 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04079296?
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 NCT04079296's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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