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

NCT02243124 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-02-21

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Eleos, Inc.

    lead INDUSTRY

Principal Investigators

  • Rami Komrokji, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243124 on ClinicalTrials.gov