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NCT02561455 · ClinicalTrials.gov registry record · Phase 1
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
A Phase 1 study of Acute Myeloid Leukemia and Advanced Solid Tumors, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 7
- Study locations
NCT02561455: Completed Phase 1 study of Acute Myeloid Leukemia and Advanced Solid Tumors, sponsored by Astellas Pharma Global Development.
NCT02561455 is a Phase 1 study of Acute Myeloid Leukemia and Advanced Solid Tumors that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 9 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02561455, a Phase 1 study of Acute Myeloid Leukemia and Advanced Solid Tumors, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of the study discontinuation criteria in the present study.
Primary Outcome
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation
Conditions Studied
Interventions
- DRUG Gilteritinib
Study Locations (7)
New York
- Site US10006 - New York
- Site US10007 - New York
Pennsylvania
- Site US10004 - Hershey
- Site US10008 - Philadelphia
Arizona
- Site US10005 - Phoenix
Maryland
- Site US10003 - Baltimore
Ohio
- Site US10001 - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-05-03 |
| Est. Completion | 2020-07-28 |
| Phase | Phase 1 |
What the finished NCT02561455 record still lists
NCT02561455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Gilteritinib is the first listed.
NCT02561455 lists 7 locations in 5 states (New York, Pennsylvania, Arizona).
Frequently Asked Questions
What is clinical trial NCT02561455 about?
NCT02561455 is a clinical study titled "Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial". The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of t...
What is the current status of trial NCT02561455?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2016-05-03. Estimated completion is 2020-07-28.
What conditions does trial NCT02561455 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Advanced Solid Tumors.
What interventions are being tested in trial NCT02561455?
The interventions under investigation include: Gilteritinib (DRUG).
Who is sponsoring clinical trial NCT02561455?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02561455 being conducted?
This trial has 7 study locations across Arizona, Maryland, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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