NCT03495167

Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

Multi-center, Open-label, Phase I Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a 7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and pharmacokinetics.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	SyB C-1101	SyB C-1101 (rigosertib sodium) will be administered to two cohorts of patients; each receives either twice daily (560 mg before breakfast and 560 mg before dinner) or twice daily (840 mg before breakfast and 280 mg before dinner. SyB C-1101 will be administered orally twice daily for 21 consecutive days, followed by a 7-day observation period. The treatment period of 28 days (21 days of administration + 7 days of observation) constitutes 1 cycle.

Timeline

• Start date: 2017-10-06
• Primary completion: 2019-05-28
• Completion: 2019-05-28
• First posted: 2018-04-11
• Last updated: 2022-11-16

Locations

9 sites across 1 country: Japan