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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 is a Phase 1 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 130 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02103478
The ClinicalTrials.gov registry entry for NCT02103478 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 130 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 3 interventions - of which ASTX727 Dose Escalation is the first listed.
NCT02103478 reports 0 study locations.
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.
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