SX-682 for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic SyndromeSX-682 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety of a new drug, SX-682, in patients with Myelodysplastic Syndromes. The goal is to find the maximum tolerated dose and identify any dose-limiting toxicities.

Eligible Conditions
  • Myelodysplastic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 28 days in the 28 day Cycle 1.

Day 28
Adverse Events
Participants Experiencing a Treatment Response
Day 28
SX-682 Single Dose Maximum Plasma Concentration (Cmax)
Day 28
SX-682 Steady-State Maximum Plasma Concentration (Css max)
SX-682 Steady-State Minimum Plasma Concentration (Css min)
Day 28
SX-682 Delayed Dose Limiting Toxicities
Day 28
SX-682 Dose Limiting Toxicities (DLT)
SX-682 Maximum Tolerated Dose (MTD)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

1 Treatment Group

Oral Dose of S-682
1 of 1

Experimental Treatment

64 Total Participants · 1 Treatment Group

Primary Treatment: SX-682 · No Placebo Group · Phase 1

Oral Dose of S-682
Drug
Experimental Group · 1 Intervention: SX-682 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 days in the 28 day cycle 1.

Who is running the clinical trial?

Syntrix Biosystems, Inc.Lead Sponsor
12 Previous Clinical Trials
603 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteOTHER
503 Previous Clinical Trials
125,952 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,592 Previous Clinical Trials
46,945,730 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,076 Previous Clinical Trials
31,020,129 Total Patients Enrolled
AdventHealthOTHER
99 Previous Clinical Trials
20,825 Total Patients Enrolled
David A Sallman, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
129 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Bilirubin is below the upper limit of normal.\n
You have a performance status of 2 or less.
You have a GFR of 30 ml/min or more.
You do not have active hepatitis B or hepatitis C.