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NCT03306264 · ClinicalTrials.gov registry record · Phase 3
Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML
A Phase 3 study, sponsored by Astex Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 227
- Enrollment target
NCT03306264 is a Phase 3 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 227 participants.
The verdict
NCT03306264, a Phase 3 study, has completed, sponsored by Astex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 227 participants
- Enrollment target
Study Summary
Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m\^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, participants continued to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the participants discontinued treatment or withdrew from the study.
Interventions
- DRUG ASTX727
- DRUG Dacogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2018-02-15 |
| Est. Completion | 2023-05-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03306264
The ClinicalTrials.gov registry entry for NCT03306264 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astex Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ASTX727 is the first listed.
NCT03306264 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03306264 about?
NCT03306264 is a clinical study titled "Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML". Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m\^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies du...
What is the current status of trial NCT03306264?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 227 participants. The study started on 2018-02-15. Estimated completion is 2023-05-25.
What interventions are being tested in trial NCT03306264?
The interventions under investigation include: ASTX727 (DRUG), Dacogen (DRUG).
Who is sponsoring clinical trial NCT03306264?
This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.
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