IRB #

STUDY00016984

Title

A Phase 1b Study Evaluating the Safety
and Pharmacokinetics of Venetoclax as a
Single-Agent and in Combination with Azacitidine in
Subjects with Relapsed/Refractory Myelodysplastic
Syndromes

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to evaluate the safety, how much of venetoclax (the study drug) and/or azacitidine are present in your body at different times, and how well the study drug works in subjects with relapsed/refractory Myelodysplastic Syndromes after standard treatment failure.

Medical Condition(s)

Myelodysplastic Syndromes
relapsed/refractory MDS

Eligibility Criteria

Relapsed MDS (disease comes back) or refractory MDS (disease did not respond to treatment)
Ability to care for one's self and able to move around by one's self
Must have failure of prior therapy with azacitidine or decitabine
Must be at least 18 years of age
Must not have received allogeneic HSCT or solid organ transplantation.
White blood cell count must be less than or equal to 10,000/µL
Must be willing to practice birth control or abstinence with partner(s) during and 30 days after study drug administration

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Participation in the trial will continue until evidence of MDS progression, the occurrence of unacceptable toxicity, death, exercise of investigator discretion, withdrawal of consent or, if clinically indicated, after discussion between investigator and the Medical Monitor on a case by case basis.

Minors Included

No

Contact

Knight Cancer Intake Center: (503)494-7999
Clinical Trials Information Line: (503)­494-­1080 or trials@ohsu.edu

Sponsor

AbbVie, Inc.

Recruitment End

05/17/2030

Compensation Provided

No


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