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Completed Phase 1Phase 2 Interventional Results available

SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

ClinicalTrials.gov ID: NCT01261312

Public ClinicalTrials.gov record NCT01261312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01261312
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Astex Pharmaceuticals, Inc.
Industry
Enrollment
414 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 4, 2011 (Actual)
Primary completion
Jul 22, 2016 (Actual)
Completion
Jul 22, 2016 (Actual)
Last update posted
Jan 23, 2025

2011 – 2016

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
Mayo Clinic Scottsdale Arizona 85259 —
University of Southern California Los Angeles California 90033 —
Yale University New Haven Connecticut 06520 —
Florida Cancer Specialists - South Fort Myers Florida 33916 —
Florida Cancer Specialists - North St. Petersburg Florida 33705 —
University of Chicago Cancer Center Chicago Illinois 60637 —
Roswell Park Cancer Institute Buffalo New York 14263 —
Cornell University New York New York 10021 —
Columbia University Medical Center New York New York 10032 —
Duke University Durham North Carolina 27705 —
Ohio State University Columbus Ohio 43210 —
Temple University Philadelphia Pennsylvania 19111 —
Sarah Cannon Research Institute Nashville Tennessee 37203 —
Tennessee Oncology Nashville Tennessee 37203 —
MD Anderson Cancer Center Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01261312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 23, 2025 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01261312 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →