drugset / Trial / NCT01700335
Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rigosertib | Small molecule | 1200 mg | Intravenous |
| Subject | rigosertib | Small molecule | 1800 mg | Intravenous |