At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
ASP7517biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Open-label 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)
In Brief
A Phase 2 clinical trial evaluating ASP7517 for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome. Completed, enrolled 43 participants across 16 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartSep 2019
Primary CompletionApr 2023
TodayJul 2026
First PostedSep 6, 2019
Enrollment StartSep 19, 2019
Primary CompletionApr 21, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.8 years ago
Interventions
ASP7517biological
Intravenous (IV)