Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
NCT ID: NCT04245397
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
151 participants
INTERVENTIONAL
2020-06-30
2029-03-31
Brief Summary
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Detailed Description
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After establishing the maximum tolerated dose 140 additional participants will be enrolled at the recommended phase 2 dose. Participants will receive continuous SX-682 twice daily oral therapy in 28-day cycles for a total of 6 cycles. The expansion dose cohort will be stratified into IPSS (a) low and intermediate-1 (N=20 SX-682 alone in HMA naive, N=20 SX-682 alone in HMA failure, N=20 SX-682 + DEC-C in HMA-naïve, N=20 SX-682 + DEC-C in HMA-failure) and (b) intermediate-2 and high risk (N=20 SX-682 alone in HMA failure, N=20 SX-682 + DEC-C in HMA-naive, N=20 SX-682 + DEC-C in HMA-failure) MDS. 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation of SX-682
Escalating oral doses of SX-682 (study drug) of 25, 50, 100, 200 and 400 mg twice-daily (i.e., 50, 100, 200, 400 and 800 mg total each day.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who have never received hypomethylating agents.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who failed on hypomethylating agents.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who have never received hypomethylating agents.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Decitabine
Decitabine is a hypomethylating agent.
Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who failed on hypomethylating agents.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Decitabine
Decitabine is a hypomethylating agent.
Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in higher risk patients who failed on hypomethylating agents.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who have never received hypomethylating agents.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Decitabine
Decitabine is a hypomethylating agent.
Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who failed on hypomethylating agents.
SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Decitabine
Decitabine is a hypomethylating agent.
Interventions
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SX-682
SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
Decitabine
Decitabine is a hypomethylating agent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk patients without 5q deletion:
i. Dose escalation portion: 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.
ii. Dose expansion portion: failed prior treatment defined as no response to treatment with at least 4 cycles started of HMA, loss of response at any time point, or progressive disease/intolerance to therapy ("HMA failure"); or no prior treatment with HMA ("HMA naive").
2. IPSS low risk or intermediate-1 risk patients with 5q deletion:
i. Dose escalation portion: failed prior treatment with at least 4 cycles started of lenalidomide and 4 cycles of hypomethylating agent (azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy.
ii. Dose expansion portion: same as non-del(5q) lower risk cohort + requirement of failed prior treatment with lenalidomide defined as no response to treatment with at least 4 cycles started of lenalidomide, loss of response at any time point, or progressive disease/intolerance to therapy.
3. IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Screening laboratory values:
1. Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
2. Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 3.0 times upper limit of normal;
3. Bilirubin \< 1.5 times upper limit of normal;
4. No history of HIV being HIV positive;
5. 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 Criteria
* 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:
1. QT interval \> 480 msec corrected using Fridericia's formula;
2. Risk factors for Torsade de Pointes;
3. Use of medication that prolongs the QT interval with the exception of drugs that are considered absolutely essential for the care of the subject;
4. Myocardial infarction ≤ 6 months prior to first day of study drug treatment;
5. 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 been cured; or patients who have been adequately treated and have low risk of reoccurrence.
* 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.
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
AdventHealth
OTHER
Emory University
OTHER
University of Miami
OTHER
Mayo Clinic
OTHER
Montefiore Medical Center
OTHER
National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Syntrix Biosystems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David A Sallman, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Mayo Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
AdventHealth Medical Group & Bone Marrow Transplant at Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Montefiore Medical Center
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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David Hodges, EMT
Role: primary
Namrata S Chandhok, MD
Role: primary
Kristen Wing, RN,BSN,CCRP
Role: primary
Charlie Riesebeck
Role: primary
Cyril Patra, MPH
Role: backup
Danielle Alexander, MS
Role: primary
Lisa A. Kelemen, RN, MSN
Role: primary
Mendel Goldfinger, MD
Role: primary
Anne Munoz, RN
Role: backup
Other Identifiers
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