drugset / Trial / NCT02014051
Safety and Pharmacokinetics Study of SyB C-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 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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rigosertib | Small molecule | 280 mg | Oral |
| Subject | rigosertib | Small molecule | 560 mg | Oral |