NCT02363491

A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome

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 or Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Opsona Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS).

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	OPN-305	For the dose confirming part of the study, patients will receive a starting dose of 5 mg/kg OPN-305.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-02-16
• Last updated: 2019-01-28

Locations

4 sites across 1 country: United States