NCT02436252

Study of DSP-7888 in Patients With Myelodysplastic Syndrome

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sumitomo Pharma Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	DSP-7888	3.5-10.5 mg/body,Id every 2-4 weeks

Timeline

• Start date: 2015-05-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2015-05-06
• Last updated: 2022-04-12

Locations

16 sites across 1 country: Japan