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NCT02864290 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02864290: Clinical Trial Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT02864290 is a Phase 1 study that was terminated before completion, 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
NCT02864290, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of ASP1235 (AGS62P1) given at three dosing schedules (Schedule A, every three weeks \[Q3W\] or Schedule B, every other week of a 4 week cycle \[Q2W\] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the anti-leukemic activity of ASP1235 (AGS62P1).
Primary Outcome
AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) grading scale, version 4.03 (National Institutes of Health, 2010).
Interventions
- DRUG ASP1235
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-11-10 |
| Est. Completion | 2020-09-03 |
| Phase | Phase 1 |
Why NCT02864290 stopped before completion
NCT02864290 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 ASP1235 is the first listed.
NCT02864290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02864290 about?
NCT02864290 is a clinical study titled "A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)". The purpose of this study is to evaluate the safety and tolerability of ASP1235 (AGS62P1) given at three dosing schedules (Schedule A, every three weeks \[Q3W\] or Schedule B, every other week of a 4 week cycle \[Q2W\] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects with acute m...
What is the current status of trial NCT02864290?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2016-11-10. Estimated completion is 2020-09-03.
What interventions are being tested in trial NCT02864290?
The interventions under investigation include: ASP1235 (DRUG).
Who is sponsoring clinical trial NCT02864290?
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 NCT02864290'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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