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NCT02103478 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
A Phase 1 study, sponsored by Astex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
NCT02103478: Completed Phase 1 study, sponsored by Astex Pharmaceuticals.
NCT02103478 is a Phase 1 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 130 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02103478, a Phase 1 study, has completed, sponsored by Astex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
Study Summary
This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.
Primary Outcome
Mean AUC0-t of oral decitabine given with cedazuridine (E7727) following IV decitabine 20 mg/m\^2 infusion on Day 5. AUCs were calculated by the linear up/log down method using the measured concentration-time values above the BQL (below the limit of quantification).
Interventions
- DRUG ASTX727 Dose Escalation
- DRUG ASTX727 Dose Confirmation
- DRUG ASTX727 Fixed-Dose Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2014-10-28 |
| Est. Completion | 2019-12-04 |
| Phase | Phase 1 |
What the finished NCT02103478 record still lists
NCT02103478 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 3 interventions - of which ASTX727 Dose Escalation is the first listed.
NCT02103478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02103478 about?
NCT02103478 is a clinical study titled "Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)". This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.
What is the current status of trial NCT02103478?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2014-10-28. Estimated completion is 2019-12-04.
What interventions are being tested in trial NCT02103478?
The interventions under investigation include: ASTX727 Dose Escalation (DRUG), ASTX727 Dose Confirmation (DRUG), ASTX727 Fixed-Dose Combination (DRUG).
Who is sponsoring clinical trial NCT02103478?
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 NCT02103478's enrollment target sits among peer trials
130 439th of 2000 higher than 1,550 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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