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NCT03730012 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03730012 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 11 participants.
The verdict
NCT03730012, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab. This study also evaluated pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores were also assessed.
Interventions
- DRUG gilteritinib
- DRUG atezolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-06-19 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03730012
The ClinicalTrials.gov registry entry for NCT03730012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which gilteritinib is the first listed.
NCT03730012 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03730012 about?
NCT03730012 is a clinical study titled "A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)". The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participa...
What is the current status of trial NCT03730012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-06-19. Estimated completion is 2021-06-15.
What interventions are being tested in trial NCT03730012?
The interventions under investigation include: gilteritinib (DRUG), atezolizumab (DRUG).
Who is sponsoring clinical trial NCT03730012?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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