At a glance
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Phase I Clinical Trial of SyB L-1101 in Patients With Myelodysplastic Syndrome
In Brief
A Phase 1 clinical trial evaluating SyB L-1101 for Myelodysplastic Syndrome. Completed, enrolled 9 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
SyB L-1101（rigosertib sodium） will be administered to two cohorts at either 1200 mg/day or 1800 mg/day. The dose will be administered intravenously for 72 continuous hours (3 days), followed by 11-day observation period. The treatment period of 14 days (3 days of administration + 11 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.