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

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT04245397
Trial Phases:	Phase I	Protocol IDs:	SX682-MDS-102 (primary) NCI-2020-04523 R44HL142389-01
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Syntrix Biosystems, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04245397

Summary

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).

Objectives

Participants will receive twice daily oral SX-682 for six 28 day cycles. If patients are
responding well to the treatment they can continue SX-682 treatment. The first
participants will be administered 25 mg orally twice daily. Unless dose limiting
toxicities occur, participants will enroll and receive the following increasing twice
daily doses of SX-682: 50 mg, 100 mg, 200 mg, and 400 mg.

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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