Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral CDAi in Patients With MDS



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:May 2014
End Date:June 2019

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)

This 2-stage, open-label study will evaluate safety and pharmacokinetics of ASTX727, as well
as determine the dose for the study's second stage. In the second stage the selected dose
will be confirmed and evaluated for clinical activity, including response rate.

Dose levels for the study's second stage will be based on safety and pharmacokinetics.

Inclusion Criteria:

- IPSS low, intermediate -1, intermediate-2, or high risk MDS (including CMML) in Dose
Escalation and Dose Confirmation-Randomization; only intermediate-2, or high risk MDS
in Dose Confirmation-Open Label

- 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

Exclusion Criteria:

- 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 AML

- Active uncontrolled gastric or duodenal ulcer

- Known history of HIV or hepatitis C or B
We found this trial at
14
sites
Medical College of Wisconsin
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Laura Michaelis, MD
Phone: 414-805-8843
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-5131
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Boston, MA
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Roswell Park Cancer Institute
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Elizabeth Griffiths, MD
Phone: 716-845-4971
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Olatoyosi Odenike, MD
Phone: 773-702-2084
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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University of Southern California
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Casey O'Connell, MD
Phone: 323-865-3879
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Vanderbilt-Ingram Cancer Center
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Michael Savona, MD
Phone: 615-875-6120
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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Johns Hopkins
Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Amy DeZern, MD
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Baltimore, MD
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Dana Faber Cancer Institute
Boston, Massachusetts 02115
Principal Investigator: David Steensma, MD
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Boston, MA
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University of Alberta Hospital
Edmonton, Alberta
Principal Investigator: Joseph Brandwein, MD
Phone: 780-407-6090
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Edmonton,
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John Theurer Cancer Center at the Hackensack University Medical Center
92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Principal Investigator: Stefan Faderl, MD
Phone: 551-996-8137
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Hackensack, NJ
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M. D. Anderson
Houston, Texas 77030
Principal Investigator: Guilermo Garcia-Manero, MD
Phone: 713-745-3010
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Houston, TX
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Horizon Oncology
Lafayette, Indiana 47905
Principal Investigator: Wael Harb, MD
Phone: 765-446-5165
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Lafayette, IN
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Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York 10021
Principal Investigator: Gail Roboz, MD
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New York, NY
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Mayo Clinic
5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Phoenix, AZ
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