CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 414 enrolled
Drug / intervention
Guadecitabinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01261312
NCT01261312Phase 2Completed
CompareCT.gov

A Phase 1-2, Dose Escalation, Multicenter Study of Two Subcutaneous Regimens of SGI-110, a DNA Hypomethylating Agent, in Subjects With Intermediate or High-Risk Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

Astex Pharmaceuticals, Inc.·interventional·Posted Dec 16, 2010·Updated Jan 23, 2025

In Brief

A Phase 2 clinical trial evaluating Guadecitabine for MDS and 2 related conditions. Completed, enrolled 414 participants across 16 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDS, CMML, AML
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2010
Enrollment StartJan 4, 2011
Primary CompletionJul 22, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.5 years ago

Interventions

Guadecitabinedrug

Subcutaneous injection