Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT02014051
Brief 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.
Study:
NCT02014051
Study Brief:
Protocol Section:
NCT02014051