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NCT01177540 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
A Phase 2 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01177540 is a Phase 2 study that was terminated before completion, run by Eisai. The registered enrollment target is 25 participants.
The verdict
NCT01177540, a Phase 2 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.
Interventions
- DRUG Decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-03-03 |
| Est. Completion | 2013-07-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01177540
The ClinicalTrials.gov registry entry for NCT01177540 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Decitabine is the first listed.
NCT01177540 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01177540 about?
NCT01177540 is a clinical study titled "Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects". The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, ...
What is the current status of trial NCT01177540?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-03-03. Estimated completion is 2013-07-19.
What interventions are being tested in trial NCT01177540?
The interventions under investigation include: Decitabine (DRUG).
Who is sponsoring clinical trial NCT01177540?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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