Myelodysplastic Syndrome Clinical Trial
SX-682 Treatment in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
Participants will receive twice daily oral SX-682 for six 28 day cycles. If patients are responding well to the treatment they can continue SX-682 treatment. The first participants will be administered 25 mg orally twice daily. Unless dose limiting toxicities occur, participants will enroll and receive the following increasing twice daily doses of SX-682: 50 mg, 100 mg, 200 mg, and 400 mg.
After establishing the maximum tolerated dose 40 additional participants will be enrolled at the maximum tolerated dose (or at the highest dose studied if a maximum tolerated dose is not identified). Participants will receive continuous SX-682 twice daily oral therapy in 28-day cycles for a total of 6 cycles. For patients responding well at the end of 6 cycles treatment may continue until disease progression or an adverse event leads to SX-682 discontinuation. Except for blood product transfusions, concurrent therapy for Myelodysplastic Syndromes is not permitted.
Diagnosis of MDS by World Health Organization criteria, and either
International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk without 5q deletion and failed treatment (no response, loss of response, progressive disease/treatment intolerance) following:
i. 4 cycles hypomethylating agent; or ii. 4 cycles hypomethylating agent, or lenalidomide or erythropoietin stimulating agent (ESA).
IPSS low risk or intermediate-1 risk with 5q deletion and failed treatment following:
i. 4 cycles of lenalidomide and hypomethylating agent; or ii. 4 cycles of lenalidomide.
IPSS intermediate-2 risk or high risk and failed treatment following 4 cycles hypomethylating agent.
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 times upper 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.
Men sexually active must use study specified contraception.
Use of chemotherapeutic agents or experimental agents for MDS within 14 days of the first 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 the first 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;
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 3 years except for local cancers that have been cured.
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 adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of 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.
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There are 5 Locations for this study
Miami Florida, 33136, United States More Info
Orlando Florida, 32804, United States More Info
Tampa Florida, 33612, United States More Info
Atlanta Georgia, 30322, United States More Info
Baltimore Maryland, 21287, United States More Info
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