Phase
Condition
White Cell Disorders
Myelodysplastic Syndromes (Mds)
Treatment
Decitabine
SX-682
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of MDS by World Health Organization criteria, and either
International Prognostic Scoring System (IPSS) low risk or intermediate-1 riskpatients without 5q deletion: i. Dose escalation portion: failed prior treatment with at least 4 cyclesstarted of a hypomethylating agent (HMA; azacitidine or decitabine) defined asno response to treatment, loss of response at any time point, or progressivedisease/intolerance to therapy. ii. Dose expansion portion: failed prior treatment defined as no response totreatment with at least 4 cycles started of HMA, loss of response at any timepoint, or progressive disease/intolerance to therapy ("HMA failure"); or noprior treatment with HMA ("HMA naive").
IPSS low risk or intermediate-1 risk patients with 5q deletion: i. Dose escalation portion: failed prior treatment with at least 4 cyclesstarted of lenalidomide and 4 cycles of hypomethylating agent (azacitidine ordecitabine) defined as no response to treatment, loss of response at any timepoint, or progressive disease/intolerance to therapy. ii. Dose expansion portion: same as non-del(5q) lower risk cohort + requirementof failed prior treatment with lenalidomide defined as no response to treatmentwith at least 4 cycles started of lenalidomide, loss of response at any timepoint, or progressive disease/intolerance to therapy.
IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve asdefined above.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Screening laboratory values:
Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 3.0 timesupper limit of normal;
Bilirubin < 1.5 times upper limit of normal;
No history of HIV being HIV positive;
No active Hepatitis B or Hepatitis C infection.
Life expectancy ≥ 12 weeks.
Women of childbearing potential (WOCBP) must use study specified contraception.
WOCBP demonstrate negative pregnancy test.
Not breastfeeding.
Men sexually active must use study specified contraception.
Exclusion
Exclusion Criteria:
Use of chemotherapeutic agents or experimental agents for MDS within 14 days of thefirst day of study drug treatment.
Use of erythroid stimulating agents, Granulocyte-colony stimulating factor (G-CSF),or Granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days of thefirst day of study drug treatment, or during the study.
Mean triplicate heart rate-corrected QT interval (QTc) > 500 msec.
Any of the following cardiac abnormalities:
QT interval > 480 msec corrected using Fridericia's formula;
Risk factors for Torsade de Pointes;
Use of medication that prolongs the QT interval with the exception of drugsthat are considered absolutely essential for the care of the subject;
Myocardial infarction ≤ 6 months prior to first day of study drug treatment;
Unstable angina pectoris or serious uncontrolled cardiac arrhythmia.
Any serious or uncontrolled medical disorder.
Prior malignancy within the previous 2 years except for local cancers that have beencured; or patients who have been adequately treated and have low risk ofreoccurrence.
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenalreplacement doses > 10 mg daily prednisone equivalents are permitted in the absenceof active autoimmune disease.
Use of other investigational drugs within 30 days of study drug administration.
Major surgery within 4 weeks of study drug administration.
Live-virus vaccination within 30 days of study drug administration.
Allergy to study drug component.
Study Design
Study Description
Connect with a study center
Mayo Clinic
Jacksonville, Florida 32224
United StatesActive - Recruiting
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
AdventHealth Medical Group & Bone Marrow Transplant at Orlando
Orlando, Florida 32804
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21287
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
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