A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02363491

A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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 an Erythropoiesis Stimulating Agent (ESA) and/or Azacitidine (AZA) followed by a dose expansion part with an additional 30 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 riskmyelodysplastic syndrome (Second line Lower risk MDS).

Status: 
Recruiting
Study Date: 
Thu, 01/01/2015 to Sun, 05/01/2016
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: OPN-305 For the dose confirming part of the study, patients will receive a starting dose of 5 mg/kg OPN-305.