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NCT01261312 · ClinicalTrials.gov registry record · Phase 1
SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
A Phase 1 study, sponsored by Astex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 414
- Enrollment target
NCT01261312 is a Phase 1 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 414 participants.
The verdict
NCT01261312, a Phase 1 study, has completed, sponsored by Astex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 414 participants
- Enrollment target
Study Summary
Phase 1-2 dose-escalation randomized study in participants with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110 with two dosing schedules in MDS and AML participants while the Dose Expansion Segment will further evaluate safety and efficacy at the biological effective dose (BED) or maximum tolerated dose (MTD) as defined in the Dose Escalation Segment.
Interventions
- DRUG Guadecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2011-01-04 |
| Est. Completion | 2016-07-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01261312
The ClinicalTrials.gov registry entry for NCT01261312 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 414 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 1 intervention - of which Guadecitabine is the first listed.
NCT01261312 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01261312 about?
NCT01261312 is a clinical study titled "SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)". Phase 1-2 dose-escalation randomized study in participants with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110 with two dosing schedules in MD...
What is the current status of trial NCT01261312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 414 participants. The study started on 2011-01-04. Estimated completion is 2016-07-22.
What interventions are being tested in trial NCT01261312?
The interventions under investigation include: Guadecitabine (DRUG).
Who is sponsoring clinical trial NCT01261312?
This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.
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