Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)



Status:Active, not recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - Any
Updated:10/28/2018
Start Date:October 6, 2014
End Date:March 27, 2020

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A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy

This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and
pharmacokinetics of orally administered ABT-199 combined with decitabine or azacitidine and
the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction
(DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199
in combination with posaconazole.


Inclusion Criteria:

- Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be
ineligible for treatment with a standard cytarabine and anthracycline induction
regimen due to co-morbidity or other factors.

- Subject must have received no prior treatment for AML with the exception of
hydroxyurea

- Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of )
to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects
greater than or equal to 60 to 74 years of age

- Subject must have adequate kidney and liver function as described in the protocol

Exclusion Criteria:

- Subject has received treatment with the following hypomethylating agent and/or chemo
therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have
been treated with other agents for AHD i.e., Myelodysplastic syndrome [MDS])

- Subject has history of Myeloproliferative Neoplasm (MPN).

- Subject has favorable risk cytogenetics as categorized by the National Comprehensive
Cancer Network Guidelines Version 2, 2014 for AML.

- Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities.

- Subject has acute promyelocytic leukemia.

- Subject has known active central nervous system involvement with AML.

- Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the
initiation of study treatment.

- Subject has a history of other malignancies .prior to study entry, with the exception
of:

- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of
breast;

- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the
skin;

- Previous malignancy confined and surgically resected (or treated with other
modalities) with curative intent.

- Subject has a white blood cell count > 25 × 10^9/L. Note: Hydroxyurea is permitted to
meet this criterion.
We found this trial at
15
sites
Durham, North Carolina 27710
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Durham, NC
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Atlanta, Georgia 30322
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Atlanta, GA
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402
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Aurora, CO
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Baltimore, Maryland 21287
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Baltimore, MD
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Boston, Massachusetts 02215
1442
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Boston, MA
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303 East Superior Street
Chicago, Illinois 60611
611
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Chicago, IL
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Chicago, Illinois 60637
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Chicago, IL
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Duarte, California 91010
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Duarte, CA
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Houston, Texas 77030
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Houston, TX
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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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1290
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from
New York, NY
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Sacramento, California 95817
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Sacramento, CA
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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Seattle, Washington 98109
1410
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from
Seattle, WA
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