NCT03337451

Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome

Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Opsona Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	OPN-305	Patients will receive study drug every 4 weeks

Timeline

• Start date: 2018-02-27
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2017-11-09
• Last updated: 2019-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study