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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: Completed Phase 3 study, sponsored by Astex Pharmaceuticals.
NCT03306264 is a Phase 3 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 227 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total 5-day ASTX727 AUC0-24 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-24 (first ASTX727 dose) was added to (Day 2 AUC0-24+ Day 5 AUC0-24) × 2. Decitabine 5-day AUC0-24 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-24+ Day 5 AUC0-24) / 2 was multiplied by 5. If AUC0-24 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-24 on Day 5; the converse was also true.
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 |
What the finished NCT03306264 record still lists
NCT03306264 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which ASTX727 is the first listed.
NCT03306264 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03306264's enrollment target sits among peer trials
227 1310th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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