drugset / Trial / NCT03495167

Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

NCT03495167

Phase 1 Completed 10 enrolled SymBio Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a 7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and pharmacokinetics.

Timeline

Start
2017-10-06
Primary completion
2019-05-28
Completion
2019-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject rigosertib Small molecule 280 mg Oral
Subject rigosertib Small molecule 560 mg Oral
Subject rigosertib Small molecule 840 mg Oral