OncoMatch/Clinical Trials/NCT04245397
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
Is NCT04245397 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including SX-682 and Decitabine for myelodysplastic syndromes.
Treatment: SX-682 · Decitabine — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage IPSS LOW RISK, IPSS INTERMEDIATE-1 RISK, IPSS INTERMEDIATE-2 RISK, IPSS HIGH RISK
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent (azacitidine, decitabine) — at least 4 cycles started
failed prior treatment with at least 4 cycles started of a hypomethylating agent (HMA; azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy
Must have received: immunomodulatory agent (lenalidomide) — at least 4 cycles started
failed prior treatment with at least 4 cycles started of lenalidomide
Cannot have received: chemotherapeutic agents or experimental agents for MDS
Use of chemotherapeutic agents or experimental agents for MDS within 14 days of the first day of study drug treatment
Cannot have received: erythroid stimulating agents
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
Cannot have received: other investigational drugs
Use of other investigational drugs within 30 days of study drug administration
Lab requirements
Kidney function
Renal glomerular filtration rate (GFR) ≥ 30 ml/min
Liver function
AST / ALT ≤ 3.0 times upper limit of normal; Bilirubin < 1.5 times upper limit of normal
Cardiac function
Mean triplicate heart rate-corrected QT interval (QTc) > 500 msec excluded; QT interval > 480 msec (Fridericia's formula) excluded; risk factors for Torsade de Pointes excluded; use of medication that prolongs QT interval excluded (except essential drugs); myocardial infarction ≤ 6 months prior excluded; unstable angina pectoris or serious uncontrolled cardiac arrhythmia excluded
Screening laboratory values: Renal glomerular filtration rate (GFR) ≥ 30 ml/min; AST / ALT ≤ 3.0 times upper limit of normal; Bilirubin < 1.5 times upper limit of normal. 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 drugs that 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic · Jacksonville, Florida
- University of Miami · Miami, Florida
- AdventHealth Medical Group & Bone Marrow Transplant at Orlando · Orlando, Florida
- Moffitt Cancer Center · Tampa, Florida
- Emory University · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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