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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Syntrix Biosystems, Inc.
Study ID
NCT04245397
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SX-682 — DRUG
    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 — DRUG
    Decitabine is a hypomethylating agent.

Study Details

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).

Key Dates

Start date
Jun 30, 2020
Status verified
Dec 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
151 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

SX-682 Maximum Tolerated Dose (MTD) [ Time Frame: Up to 28 days in the 28 day Cycle 1. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
David Hodges, EMT
[email protected]
904-953-5200
Hemant S Murthy, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Namrata S Chandhok, MD
[email protected]
305-243-8238
Namrata S Chandhok, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth Medical Group & Bone Marrow Transplant at OrlandoOrlandoFlorida32804
Kristen Wing, RN,BSN,CCRP
[email protected]
407-303-8251
Arlene Gayle, M.D. (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Charlie Riesebeck
[email protected]
813-745-3884
Cyril Patra, MPH
[email protected]
813-745-2802
David A Sallman, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Danielle Alexander, MS
[email protected]
404-778-3663
Anthony M Hunter, MD (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287
Lisa A. Kelemen, RN, MSN
[email protected]
410-614-4618
Amy E DeZern, MD, MHS (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Mendel Goldfinger, MD
[email protected]
Anne Munoz, RN
[email protected]
718-920-2006
Mendel Goldfinger, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic· Jacksonville, FLUniversity of Miami· Miami, FLAdventHealth Medical Group & Bone Marrow Transplant at Orlando· Orlando, FLMoffitt Cancer Center· Tampa, FLEmory University· Atlanta, GASidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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