drugset / Trial / NCT02014051

Safety and Pharmacokinetics Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)

NCT02014051

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

Summary

The purpose of this study is to investigate tolerability when SyB C-1101 is orally administered twice daily for 14 consecutive days to the patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be investigated.

Timeline

Start
2013-03
Primary completion
2014-11
Completion
2014-11

Drugs

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