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NCT02752035 · ClinicalTrials.gov registry record · Phase 3
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 183
- Enrollment target
NCT02752035 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 183 participants.
The verdict
NCT02752035, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 183 participants
- Enrollment target
Study Summary
This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some participants with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster. For participants with AML who could not receive standard chemotherapy, azacitidine (also known as Vidaza®) was a current standard of care treatment option in the United States. This clinical study tested an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib worked by stopping the leukemia cells from making the FLT3 protein. This helped stop the leukemia cells from growing faster. This study compared two different treatments. Participants were assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There was a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.
Interventions
- DRUG azacitidine
- DRUG gilteritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02752035
The ClinicalTrials.gov registry entry for NCT02752035 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 183 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 azacitidine is the first listed.
NCT02752035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02752035 about?
NCT02752035 is a clinical study titled "A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy". This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some participants with AML have a mutation, or change, in the...
What is the current status of trial NCT02752035?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 183 participants. The study started on 2016-08-01. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT02752035?
The interventions under investigation include: azacitidine (DRUG), gilteritinib (DRUG).
Who is sponsoring clinical trial NCT02752035?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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