Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)

Completed · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndrome, MDS

In brief

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.

Key facts

Study ID

NCT02103478

Run by

Astex Pharmaceuticals, Inc.

People needed

130

Starts

2014-10-28

Expected to finish

2019-12-04

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• International Prognostic Scoring System (IPSS) low, intermediate -1, intermediate-2, or high risk MDS (including chronic myelomonocytic leukemia; CMML) in Dose Escalation and Dose Confirmation-Randomization; only intermediate-2, or high risk MDS in Dose Confirmation-Open Label
• Eastern Cooperative Oncology Group (ECOG) 0 to 2
• No major surgery within 2 weeks of starting study treatment
• No cytotoxic chemotherapy within 2 weeks of starting study treatment
• Able to swallow pills

You may not qualify if…

• Previous treatment with 2 or more courses of decitabine (all stages) or azacitidine (Dose Confirmation stage only)
• Treatment with investigational therapy within 2 weeks of study treatment
• Uncontrolled medical disease(s) or active, uncontrolled infection
• Diagnosed with acute myeloid leukemia (AML)
• Active uncontrolled gastric or duodenal ulcer
• Known history of HIV or hepatitis C or B

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• University of Chicago — Chicago, Illinois, United States
• Horizon Oncology — Lafayette, Indiana, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• John Theurer Cancer Center/ Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medical College - New York Presbyterian Hospital — New York, New York, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• M. D. Anderson — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Sunnybrook Health Sciences Centre, Odette Cancer Centre — Toronto, Ontario, Canada
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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