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 (Jun 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
Treatments studied
Chemotherapy
Other
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 →Frequently asked questions
Is NCT04245397 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapeutic agents or experimental agents for MDS, erythroid stimulating agents, other investigational drugs disqualifies patients from enrollment.
What disease stage is eligible?
Stage IPSS LOW RISK or IPSS INTERMEDIATE-1 RISK or IPSS INTERMEDIATE-2 RISK or IPSS HIGH RISK is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages