NCT02014051

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

Phase I Clinical Trial 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

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.

Detailed description

In Cohort 1, SyB C-1101 280 mg/dose group, Participants will be administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period. In Cohort 2, SyB C-1101 560 mg/dose group, Participants will be administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period. In both Cohorts, the treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles. The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	SyB C-1101	SyB C-1101（rigosertib sodium） will be administered to two cohorts at either 280 mg/day or 560 mg/day. The dose will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days (14 days of administration + 7 days of observation) constitutes 1 cycle. The study will involve treatment through the second cycle, but treatment can be continued for 3 or more cycles if conditions for continued administration are satisfied. However, treatment will be limited to a maximum of 6 cycles including the first cycle.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-12-17
• Last updated: 2022-11-21
• Results posted: 2016-09-14

Locations

4 sites across 1 country: Japan