drugset / Trial / NCT01700335

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

NCT01700335

Phase 1 Completed 9 enrolled SymBio Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate tolerability when SyB L-1101 is administered intravenously in 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
2012-06
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject rigosertib Small molecule 1200 mg Intravenous
Subject rigosertib Small molecule 1800 mg Intravenous