A Phase 1b Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax as Single Agent and in Combination with Azacitidine in Subjects with Higher-Risk Myelodysplastic Syndromes after Hypomethylating Agent Failure

Protocol: 
AAAR1076
Phase: 
I

A Phase 1b Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax as Single Agent and in Combination with Azacitidine in Subjects with Higher-Risk Myelodysplastic Syndromes after Hypomethylating Agent Failure

The purpose of this study is to evaluate the safety, pharmacokinetics (how much of the study drug[s] is present in your body at different times), and efficacy (how well the study treatment works) of venetoclax alone and of venetoclax in combination with azacitidine in subjects with higher-risk MDS after HMA-failure.

Are you Eligible? (Inclusion Criteria)

1) Subjects must be at least 18 years of age.

2) Subjects must have been unsuccessfully treated with azacitidine or
decitabine previously.

3) Subjects must be in good physical health. This means that the patient
should be capable of all self-care, even if they are unable to carry out any
work activities, and should be up and about more than half of waking hours.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States