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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

October 28, 2014

Primary Completion Date

June 5, 2018

Study Completion Date

December 4, 2019

Conditions
Myelodysplastic SyndromeMDS
Interventions
DRUG

ASTX727 Dose Escalation

Oral investigational product and approved IV decitabine

DRUG

ASTX727 Dose Confirmation

Randomization cross over design for courses 1 and 2

DRUG

ASTX727 Fixed-Dose Combination

Fixed-dose investigational product

Trial Locations (17)

10021

Weill Cornell Medical College - New York Presbyterian Hospital, New York

14263

Roswell Park Cancer Institute, Buffalo

21231

Johns Hopkins, Baltimore

37232

Vanderbilt Ingram Cancer Center, Nashville

47905

Horizon Oncology, Lafayette

53226

Medical College of Wisconsin, Milwaukee

60637

University of Chicago, Chicago

77030

M. D. Anderson, Houston

85054

Mayo Clinic, Phoenix

90024

University of Southern California, Los Angeles

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

07601

John Theurer Cancer Center/ Hackensack University Medical Center, Hackensack

T6G 2G3

University of Alberta Hospital, Edmonton

M4N 3M5

Sunnybrook Health Sciences Centre, Odette Cancer Centre, Toronto

M5G 2M9

Princess Margaret Cancer Center, Toronto

H1T 2M4

Hôpital Maisonneuve-Rosemont, Montreal

Sponsors
All Listed Sponsors
lead

Astex Pharmaceuticals, Inc.

INDUSTRY