A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Subjects With Relapsed/Refractory Myelodysplastic Syndromes (MDS)



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:March 7, 2017
End Date:August 4, 2020
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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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

This is a Phase 1b, open-label, multicenter study designed to evaluate the safety and
pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in
participants with relapsed/refractory Myelodysplastic Syndromes (MDS).


Inclusion Criteria:

- Subjects who have relapsed or refractory MDS.

- Subject enrolled in venetoclax monotherapy must have documented failure of prior
therapy with a hypomethylating agent (HMA). HMA-failure is defined as:

1. Relapse after initial complete or partial response or hematological improvement
after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within
the last 5 years, OR

2. Failure to achieve complete or partial response or hematological improvement
after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within
the last 5 years

- Subjects must have presence of < 20% bone marrow blasts per bone marrow
biopsy/aspirate at screening.

- Subject is not a candidate to undergo allogenic hematopoietic stem cell
transplantation (HSCT).

- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of
≤2.

- Subject must have adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

- Subject has received prior therapy with a BH3 mimetic.

- Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).

- Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic
myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable
MDS/MPN.

- Subject has received allogeneic HSCT or solid organ transplantation.

- Subject has received a live attenuated vaccine within 4 weeks prior to the first dose
of study drug.

- Subject is pregnant or breastfeeding.
We found this trial at
11
sites
1501 North Campbell Avenue
Tucson, Arizona 85724
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Aurora, Colorado 80045
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Aurora, CO
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Boston, Massachusetts 02114
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Boston, MA
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Boston, Massachusetts 02215
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
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Chicago, IL
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Houston, Texas 77030
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Houston, TX
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Kogarah, New South Wales
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Kogarah,
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New Haven, Connecticut 06510
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New Haven, CT
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New York, NY
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Portland, OR
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Worcester, Massachusetts 01655
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Worcester, MA
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