RECRUITING

Study of SX-682 Alone and in Combination with Oral or Intravenous Decitabine in Subjects with Myelodysplastic Syndrome

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Conditions

Myelodysplastic SyndromesImmunotherapyChemokine receptor blockadeMyeloid-derived supressor cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1, Open-Label, Dose-Escalation with Expansion Study of SX-682 Alone and in Combination with Oral or Intravenous Decitabine in Subjects with Myelodysplastic Syndrome

Quick Facts

Study Start:2020-06-30
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04245397

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of MDS by World Health Organization criteria, and either
  2. 1. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk patients without 5q deletion:
  3. 2. IPSS low risk or intermediate-1 risk patients with 5q deletion:
  4. 3. IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  6. * Screening laboratory values:
  7. 1. Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
  8. 2. Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 3.0 times upper limit of normal;
  9. 3. Bilirubin \< 1.5 times upper limit of normal;
  10. 4. No history of HIV being HIV positive;
  11. 5. No active Hepatitis B or Hepatitis C infection.
  12. * Life expectancy ≥ 12 weeks.
  13. * Women of childbearing potential (WOCBP) must use study specified contraception.
  14. * WOCBP demonstrate negative pregnancy test.
  15. * Not breastfeeding.
  16. * Men sexually active must use study specified contraception.
  1. * Use of chemotherapeutic agents or experimental agents for MDS within 14 days of the first day of study drug treatment.
  2. * 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.
  3. * Mean triplicate heart rate-corrected QT interval (QTc) \> 500 msec.
  4. * Any of the following cardiac abnormalities:
  5. 1. QT interval \> 480 msec corrected using Fridericia's formula;
  6. 2. Risk factors for Torsade de Pointes;
  7. 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;
  8. 4. Myocardial infarction ≤ 6 months prior to first day of study drug treatment;
  9. 5. Unstable angina pectoris or serious uncontrolled cardiac arrhythmia.
  10. * Any serious or uncontrolled medical disorder.
  11. * 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.
  12. * 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.
  13. * Use of other investigational drugs within 30 days of study drug administration.
  14. * Major surgery within 4 weeks of study drug administration.
  15. * Live-virus vaccination within 30 days of study drug administration.
  16. * Allergy to study drug component.

Contacts and Locations

Study Contact

Aaron D Schuler, PhD
CONTACT
253-833-8009
aschuler@syntrixbio.com

Principal Investigator

David A Sallman, MD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Mayo Clinic
Jacksonville, Florida, 32224
United States
University of Miami
Miami, Florida, 33136
United States
AdventHealth Medical Group & Bone Marrow Transplant at Orlando
Orlando, Florida, 32804
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Emory University
Atlanta, Georgia, 30322
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States
Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Syntrix Biosystems, Inc.

  • David A Sallman, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-30
Study Completion Date2029-03

Study Record Updates

Study Start Date2020-06-30
Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

  • Immunotherapy
  • Chemokine receptor blockade
  • Myeloid-derived supressor cells

Additional Relevant MeSH Terms

  • Myelodysplastic Syndromes