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Study of DSP-7888 in Patients With Myelodysplastic Syndrome — MDS  

Myelodysplastic Syndrome Clinical Trial

Official title:
Phase 1/2 Study of DSP-7888 in Patients With Myelodysplastic Syndrome (MDS)

Clinical Trial Summary

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist.

Clinical Trial Description

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist. In the Phase 1 part, high risk and low risk patients with MDS requiring additional treatment will be enrolled, and two different dose levels of DSP-7888 (3.5 and 10.5 mg/body) will be investigated in a stepwise manner starting with the lower dose using the 3+3 design, to determine the MTD and the RD for the Phase 2 part based on DLT evaluation during the 29 days following the initial dose of DSP-7888. In the Phase 2 part, DSP-7888 therapy at the RD determined by the Phase 1 part will be administered to high risk patients with MDS who had received and not responded to azacitidine as a standard treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02436252
Study type Interventional
Source Sumitomo Pharma Co., Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 2015
Completion date March 2020
View Details
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