NCT02243124

A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome (MDS)

A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Eleos, Inc. · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to test the safety of six cycles of cenersen treatment and to begin to test the hypothesis that intermittent administration of cenersen may lead to a reduced dependence on transfusion.

Detailed description

The study is a nonrandomized open-label treatment with varying doses of cenersen by intravenous administration to: Primary \*To assess the safety profile and dose limiting toxicities (DLT) of cenersen for each of three increasing dose levels as stipulated by the protocol in patients with lower risk MDS defined as low or intermediate-1 risk by IPSS. Secondary * To determine the lowest pharmacologically active exposure from among three increasing dose levels as stipulated by the protocol that exhibits the desired activity on erythropoiesis after evaluation of all dose levels, and * To determine if intermittent treatment with cenersen will reduce transfusion requirements for patients with lower risk MDS.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	cenersen	cenersen is a phosphorothioate antisense oligonucleotide that down-regulates the production of both wild-type and mutant p53, and has a RNase H-dependent mechanism of action
DRUG	Dexamethasone	Optionally, Dexamethasone 20 mg po weekly can be added after week 16 if stable disease but no HI is observed.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-30
• Completion: 2015-12-31
• First posted: 2014-09-17
• Last updated: 2021-02-21

Locations

1 site across 1 country: United States