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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: Completed Phase 1 study, sponsored by Astex Pharmaceuticals.
NCT01261312 is a Phase 1 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 414 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (590% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DNA LINE-1 demethylation is defined as the largest percent decrease from baseline in methylation values within a participant between Day 8 and Day 22 of the first treatment cycle. BED was assessed based on DNA LINE-1 demethylation results and defined as the smallest dose that achieves the maximum biological pharmacodynamic (PD) effect (LINE-1 demethylation) in at least 3 successive dose levels.
Interventions
- DRUG Guadecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2011-01-04 |
| Est. Completion | 2016-07-22 |
| Phase | Phase 1 |
What the finished NCT01261312 record still lists
NCT01261312 is an interventional study that assigns participants to a tested intervention. The registered 414 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 (590% higher).
The record links to 0 conditions, and to 1 intervention - of which Guadecitabine is the first listed.
NCT01261312 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01261312's enrollment target sits among peer trials
414 71st of 2000 higher than 1,929 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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