NCT02000154

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

Phase I Clinical Trial of SyB L-1101 in Patients With Myelodysplastic Syndrome - Extension Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is an extension study study to investigate long term safety of SyB L-1101 when administered intravenously every 4 weeks to the patients who have completed 8 cycles in the study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome. Antitumor effects will also be investigated in this study.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	SyB L-1101	SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period. The treatment period of 28 days (3 days of administration + 25 days of observation) constitutes 1 cycle. The dose at cycle 8 in the study 2011005 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 9). From cycle 10 on, the dose of SyB L-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-12-03
• Last updated: 2017-03-31
• Results posted: 2017-03-31

Locations

9 sites across 1 country: Japan